{"id":3523,"date":"2021-05-13T11:29:32","date_gmt":"2021-05-13T04:29:32","guid":{"rendered":"https:\/\/www.squat.in.th\/en\/?p=3523"},"modified":"2025-10-22T21:16:02","modified_gmt":"2025-10-22T14:16:02","slug":"mds-vv-ep1","status":"publish","type":"post","link":"https:\/\/www.squat.in.th\/en\/mds-vv-ep1\/","title":{"rendered":"Medical Device Software Standards (Part 1)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3523\" class=\"elementor elementor-3523\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-597b5bf elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"597b5bf\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0419646\" data-id=\"0419646\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e8b9896 elementor-widget elementor-widget-text-editor\" data-id=\"e8b9896\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"margin: 0cm; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; caret-color: #000000; color: #000000; text-align: left;\"><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0<\/span><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">\u00a0<\/span><b style=\"font-family: Aptos, sans-serif;\"><span lang=\"EN-US\">Ensuring Safety and Reliability Through International Standards<\/span><\/b><\/p><p><style>\n<!-- \/* Style Definitions *\/ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:\"\"; margin-top:0cm; margin-right:0cm; margin-bottom:8.0pt; margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:15.0pt; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-font-kerning:1.0pt; mso-ligatures:standardcontextual; mso-ansi-language:EN-US;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US;} .MsoPapDefault {mso-style-type:export-only; margin-bottom:8.0pt; line-height:115%;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} \/* List Definitions *\/ @list l0 {mso-list-id:1171486873; mso-list-template-ids:-1870363692;} @list l0:level1 {mso-level-number-format:bullet; mso-level-text:\uf0b7; mso-level-tab-stop:36.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Symbol;} @list l0:level2 {mso-level-number-format:bullet; mso-level-text:o; mso-level-tab-stop:72.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:\"Courier New\"; mso-bidi-font-family:\"Times New Roman\";} @list l0:level3 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:108.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level4 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:144.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level5 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:180.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level6 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:216.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level7 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:252.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level8 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:288.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level9 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:324.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} --><br \/><\/style><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">Medical devices and medical device software play a crucial role in modern healthcare \u2014 saving lives, improving patient outcomes, and supporting physicians in diagnosis and treatment. Because these devices directly impact human health, their performance must be\u00a0<b>accurate, reliable, and safe<\/b>.<\/span><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">To ensure this, medical device manufacturers are subject to strict\u00a0<b>quality and regulatory control<\/b>\u00a0by each country\u2019s\u00a0<b>Food and Drug Administration (FDA)<\/b>\u00a0or equivalent authority. These regulations are based on\u00a0<b>international standards<\/b>\u00a0that govern design, manufacturing, and testing. Among the most widely recognized are:<\/span><\/p><ul style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; margin-top: 0cm;\" type=\"disc\"><li><b><span lang=\"EN-US\">ISO 13485<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Quality Management Systems for Medical Devices<\/span><\/li><li><b><span lang=\"EN-US\">ISO 14971<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Risk Management for Medical Devices<\/span><\/li><li><b><span lang=\"EN-US\">IEC 60601<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Safety and Performance of Medical Electrical Equipment<\/span><\/li><\/ul><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">For\u00a0<b>medical device software<\/b>, additional standards apply \u2014 particularly\u00a0<b>IEC 60601-1, Clause 14<\/b>\u00a0and\u00a0<b>IEC 62304<\/b>, which define processes for developing, testing, and maintaining safe software systems. Manufacturers seeking international compliance must also understand\u00a0<b>Software Verification and Validation (V&amp;V)<\/b>principles to ensure that software functions correctly, precisely, and safely when used on humans.<\/span><\/p><div style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000; text-align: center;\" align=\"center\"><hr align=\"center\" size=\"0\" width=\"100%\" \/><\/div><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">Purpose of This Series<\/span><\/b><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">This article, the first in a series, provides an\u00a0<b>overview of IEC 60601-1 Clause 14 and IEC 62304<\/b>, and introduces the\u00a0<b>principles of software verification and validation<\/b>. It aims to help\u00a0<b>medical device software developers<\/b>\u00a0gain foundational knowledge to prepare for compliant software production and certification.<\/span><\/p><div>\u00a0<\/div><p><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m1.jpg\" alt=\"\" width=\"932\" height=\"495\" \/>\u0e23\u0e39\u0e1b\u0e17\u0e35\u0e48 1 \u0e23\u0e30\u0e1a\u0e1a<\/p><p><i style=\"caret-color: #000000; color: #000000;\"><span lang=\"EN-US\" style=\"font-size: 12pt; line-height: 18.4px; font-family: Aptos, sans-serif;\">F<b>igure 1: Key organizations supporting product quality and standardization.<\/b><\/span><\/i><\/p><div><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">\u00a0<\/span><\/div><div><p><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">\u00a0 \u00a0<\/span><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">The<\/span><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">\u00a0<\/span><b style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif;\">digital product quality ecosystem<\/b><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">\u00a0<\/span><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">involves multiple organizations working together to ensure the quality and safety of medical devices:<\/span><\/p><style>\n<!-- \/* Style Definitions *\/ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:\"\"; margin-top:0cm; margin-right:0cm; margin-bottom:8.0pt; margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:15.0pt; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-font-kerning:1.0pt; mso-ligatures:standardcontextual; mso-ansi-language:EN-US;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US;} .MsoPapDefault {mso-style-type:export-only; margin-bottom:8.0pt; line-height:115%;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} \/* List Definitions *\/ @list l0 {mso-list-id:1192886318; mso-list-template-ids:1129744976;} @list l1 {mso-list-id:1589773717; mso-list-template-ids:-1030171438;} @list l1:level1 {mso-level-number-format:bullet; mso-level-text:\uf0b7; mso-level-tab-stop:36.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Symbol;} @list l1:level2 {mso-level-number-format:bullet; mso-level-text:o; mso-level-tab-stop:72.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:\"Courier New\"; mso-bidi-font-family:\"Times New Roman\";} @list l1:level3 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:108.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l1:level4 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:144.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l1:level5 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:180.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l1:level6 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:216.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l1:level7 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:252.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l1:level8 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:288.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l1:level9 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:324.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} --><br \/><\/style><ol style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; margin-top: 0cm;\" start=\"1\" type=\"1\"><li><b><span lang=\"EN-US\">Schema Owner<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Defines frameworks and reference models for product certification.<\/span><\/li><li><b><span lang=\"EN-US\">Promoter<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Provides support measures, including financial aid for testing or standard compliance.<\/span><\/li><li><b><span lang=\"EN-US\">Regulatory Body<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Establishes and enforces standards, reviews product registration, and authorizes market release.<\/span><\/li><li><b><span lang=\"EN-US\">Testing Laboratory (Testing Lab)<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Conducts product testing according to relevant standards.<\/span><\/li><li><b><span lang=\"EN-US\">Certification Body (Certified Body)<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Certifies products using test results from accredited laboratories.<\/span><\/li><\/ol><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">After passing testing and\/or certification, manufacturers submit documentation to the\u00a0<b>Regulatory Body<\/b>\u00a0for product registration and approval to market their devices.<\/span><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">In Thailand, this role is held by the\u00a0<b>Food and Drug Administration (FDA)<\/b>, which defines medical device standards and recognizes specific\u00a0<b>Testing Labs<\/b>\u00a0and\u00a0<b>Certification Bodies<\/b>\u00a0authorized to issue compliant test reports and certifications.<\/span><\/p><div style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000; text-align: center;\" align=\"center\"><hr align=\"center\" size=\"0\" width=\"100%\" \/><\/div><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">Medical Device Standards: An Interconnected Framework<\/span><\/b><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">Medical device development draws on several interconnected international standards, including:<\/span><\/p><ul style=\"margin-bottom: 0cm; margin-top: 0cm;\" type=\"disc\"><li style=\"caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">ISO 13485<\/span><\/b><span lang=\"EN-US\">\u00a0and\u00a0<b>ISO 14971<\/b>\u00a0for design and risk management<\/span><\/li><li style=\"caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">IEC 60601<\/span><\/b><span lang=\"EN-US\">\u00a0for electrical safety and performance<\/span><\/li><li style=\"caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">IEC 60601-1 Clause 14<\/span><\/b><span lang=\"EN-US\">\u00a0and\u00a0<b>IEC 62304<\/b>\u00a0for software development and life cycle management<\/span><\/li><\/ul><div><span style=\"color: #000000;\"><span style=\"caret-color: #000000;\">\u00a0<\/span><\/span><\/div><p><img decoding=\"async\" class=\"size-full wp-image-3540\" src=\"https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m2.png\" alt=\"\" width=\"802\" height=\"429\" srcset=\"https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m2.png 802w, https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m2-300x160.png 300w, https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m2-768x411.png 768w\" sizes=\"(max-width: 802px) 100vw, 802px\" \/><\/p><p style=\"text-align: center;\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem; caret-color: #000000; color: #000000;\">Figure 2: Relationship among standards related to medical device software.<\/span><\/p><p style=\"text-align: center;\"><span style=\"color: #000000; caret-color: #000000; font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">(Source: ANSI\/AAMI\/IEC 62304:2006 \u2013 Medical Device Software\u2014Software Life Cycle Processes)<\/span><\/p><div><span style=\"color: #000000;\"><span style=\"caret-color: #000000;\">\u00a0<\/span><\/span><\/div><p style=\"margin: 0cm 0cm 8pt; line-height: 18.4px; font-size: medium; font-family: Aptos, sans-serif; caret-color: #000000; color: #000000; font-style: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: auto; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration: none;\"><span lang=\"EN-US\">In addition, several complementary standards support IEC 62304 implementation:<\/span><\/p><style>\n<!-- \/* Style Definitions *\/ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:\"\"; margin-top:0cm; margin-right:0cm; margin-bottom:8.0pt; margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:15.0pt; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-font-kerning:1.0pt; mso-ligatures:standardcontextual; mso-ansi-language:EN-US;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US;} .MsoPapDefault {mso-style-type:export-only; margin-bottom:8.0pt; line-height:115%;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} \/* List Definitions *\/ @list l0 {mso-list-id:1709718824; mso-list-template-ids:-970030116;} @list l0:level1 {mso-level-number-format:bullet; mso-level-text:\uf0b7; mso-level-tab-stop:36.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Symbol;} @list l0:level2 {mso-level-number-format:bullet; mso-level-text:o; mso-level-tab-stop:72.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:\"Courier New\"; mso-bidi-font-family:\"Times New Roman\";} @list l0:level3 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:108.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level4 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:144.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level5 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:180.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level6 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:216.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level7 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:252.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level8 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:288.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level9 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:324.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} --><br \/><\/style><ul style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; margin-top: 0cm;\" type=\"disc\"><li><b><span lang=\"EN-US\">IEC\/ISO 12207<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Defines software life cycle processes (the \u201cwhat\u201d of development).<\/span><\/li><li><b><span lang=\"EN-US\">IEC\/ISO 90003<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Provides guidelines on software engineering practices (the \u201chow\u201d).<\/span><\/li><li><b><span lang=\"EN-US\">IEC 61508-3<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Covers functional safety for electronic and programmable systems, often referenced for safety-critical software testing.<\/span><\/li><\/ul><div><span style=\"color: #000000;\"><span style=\"caret-color: #000000;\">\u00a0<\/span><\/span><\/div><style>\n<!-- \/* Style Definitions *\/ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:\"\"; margin-top:0cm; margin-right:0cm; margin-bottom:8.0pt; margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:15.0pt; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-font-kerning:1.0pt; mso-ligatures:standardcontextual; mso-ansi-language:EN-US;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US;} .MsoPapDefault {mso-style-type:export-only; margin-bottom:8.0pt; line-height:115%;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} \/* List Definitions *\/ @list l0 {mso-list-id:1434856668; mso-list-template-ids:1920231286;} @list l0:level1 {mso-level-number-format:bullet; mso-level-text:\uf0b7; mso-level-tab-stop:36.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Symbol;} @list l0:level2 {mso-level-number-format:bullet; mso-level-text:o; mso-level-tab-stop:72.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:\"Courier New\"; mso-bidi-font-family:\"Times New Roman\";} @list l0:level3 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:108.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level4 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:144.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level5 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:180.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level6 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:216.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level7 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:252.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level8 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:288.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level9 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:324.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} --><br \/><\/style><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">Understanding IEC 62304<\/span><\/b><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">IEC 62304 establishes a structured framework for developing medical device software through six key clauses (4\u20139):<\/span><\/p><ul style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; margin-top: 0cm;\" type=\"disc\"><li><b><span lang=\"EN-US\">Software Development Planning<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Risk Management Integration<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Software Design and Implementation<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Verification and Validation<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Maintenance Processes<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Problem Resolution Management<\/span><\/b><\/li><\/ul><p><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">These requirements collectively ensure that software products meet<\/span><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">\u00a0<\/span><b style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif;\">safety, quality, and traceability<\/b><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">expectations throughout their entire life cycle. Each clause will be discussed in detail in<\/span><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">\u00a0<\/span><b style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif;\">Part 2<\/b><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">\u00a0<\/span><span style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif; font-size: medium;\">of this series.<\/span><\/p><p style=\"margin: 0cm 0cm 8pt; line-height: 18.4px; font-size: medium; font-family: Aptos, sans-serif; caret-color: #000000; color: #000000; font-style: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: auto; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration: none;\"><b><span lang=\"EN-US\">What Counts as \u201cSoftware\u201d?<\/span><\/b><\/p><p style=\"margin: 0cm 0cm 8pt; line-height: 18.4px; font-size: medium; font-family: Aptos, sans-serif; caret-color: #000000; color: #000000; font-style: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: auto; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration: none;\"><span lang=\"EN-US\">Under IEC 62304,\u00a0<i>software<\/i>\u00a0is defined broadly to include:<\/span><\/p><ol style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; font-style: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: auto; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: auto; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration: none; margin-top: 0cm;\" start=\"1\" type=\"1\"><li style=\"mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;\"><b><span lang=\"EN-US\">Program instructions (code)<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 both compiled and uncompiled.<\/span><\/li><li style=\"mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;\"><b><span lang=\"EN-US\">Data structures and related data<\/span><\/b><span lang=\"EN-US\">.<\/span><\/li><li style=\"mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;\"><b><span lang=\"EN-US\">All documentation and artifacts<\/span><\/b><span lang=\"EN-US\">\u00a0produced during software development, such as:<\/span><br \/><ul style=\"margin-bottom: 0cm; margin-top: 0cm;\" type=\"circle\"><li style=\"mso-list: l0 level2 lfo1; tab-stops: list 72.0pt;\"><span lang=\"EN-US\">Software Development Plans<\/span><\/li><li style=\"mso-list: l0 level2 lfo1; tab-stops: list 72.0pt;\"><span lang=\"EN-US\">Software Requirements Specifications<\/span><\/li><li style=\"mso-list: l0 level2 lfo1; tab-stops: list 72.0pt;\"><span lang=\"EN-US\">Risk Analysis Reports<\/span><\/li><li style=\"mso-list: l0 level2 lfo1; tab-stops: list 72.0pt;\"><span lang=\"EN-US\">Design Documents<\/span><\/li><li style=\"mso-list: l0 level2 lfo1; tab-stops: list 72.0pt;\"><span lang=\"EN-US\">Source Code<\/span><\/li><li style=\"mso-list: l0 level2 lfo1; tab-stops: list 72.0pt;\"><span lang=\"EN-US\">Test Cases and Test Reports<\/span><\/li><\/ul><\/li><\/ol><style>\n<!-- \/* Style Definitions *\/ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:\"\"; margin-top:0cm; margin-right:0cm; margin-bottom:8.0pt; margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:15.0pt; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-font-kerning:1.0pt; mso-ligatures:standardcontextual; mso-ansi-language:EN-US;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US;} .MsoPapDefault {mso-style-type:export-only; margin-bottom:8.0pt; line-height:115%;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} \/* List Definitions *\/ @list l0 {mso-list-id:1329749922; mso-list-template-ids:1286387988;} @list l0:level2 {mso-level-number-format:bullet; mso-level-text:o; mso-level-tab-stop:72.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:\"Courier New\"; mso-bidi-font-family:\"Times New Roman\";} --><br \/><\/style><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">This holistic definition reinforces that software quality depends not only on the code itself but also on the surrounding engineering and validation processes.<\/span><\/p><p><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">\u00a0<\/span><b style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif;\"><span lang=\"EN-US\">Types of Medical Device Software<\/span><\/b><\/p><p><b style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif;\"><span lang=\"EN-US\">\u00a0<\/span><\/b><\/p><p><b style=\"caret-color: #000000; color: #000000; font-family: Aptos, sans-serif;\"><span lang=\"EN-US\"> <img decoding=\"async\" class=\"aligncenter size-full wp-image-3541\" src=\"https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m3.png\" alt=\"\" width=\"541\" height=\"291\" srcset=\"https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m3.png 541w, https:\/\/www.squat.in.th\/en\/wp-content\/uploads\/2021\/05\/m3-300x161.png 300w\" sizes=\"(max-width: 541px) 100vw, 541px\" \/><\/span><\/b><\/p><p style=\"text-align: center;\"><strong>Figure 3: Examples of medical device software (source: <a href=\"https:\/\/www.medicalexpo.com\/prod\/micrel-medical-devices\/product-69404-505756.html\">Micrel Medical Devices<\/a>)<\/strong><\/p><\/div><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">Medical device software typically falls into two main categories:<\/span><\/p><ol style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; margin-top: 0cm;\" start=\"1\" type=\"1\"><li><b><span lang=\"EN-US\">Embedded Software<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 Integrated into the hardware of a medical device, responsible for sensor data acquisition and control functions. Example:\u00a0<i>Infusion pumps<\/i>\u00a0that regulate intravenous fluid delivery.<\/span><\/li><li><b><span lang=\"EN-US\">Application or Standalone Software<\/span><\/b><span lang=\"EN-US\">\u00a0\u2013 External applications that interact with embedded systems to display, control, or transmit data. These may take the form of\u00a0<b>web<\/b>,\u00a0<b>mobile<\/b>, or\u00a0<b>desktop applications<\/b>, communicating with devices via\u00a0<b>Wi-Fi<\/b>,\u00a0<b>Bluetooth<\/b>, or\u00a0<b>cloud platforms<\/b>.<\/span><\/li><\/ol><div><span style=\"color: #000000;\"><span style=\"caret-color: #000000;\">\u00a0<\/span><\/span><\/div><div><span style=\"color: #000000;\"><span style=\"caret-color: #000000;\">\u00a0<\/span><\/span><\/div><div><style>\n<!-- \/* Style Definitions *\/ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:\"\"; margin-top:0cm; margin-right:0cm; margin-bottom:8.0pt; margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:15.0pt; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-font-kerning:1.0pt; mso-ligatures:standardcontextual; mso-ansi-language:EN-US;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:\"Aptos\",sans-serif; mso-ascii-font-family:Aptos; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Aptos; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Aptos; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:\"Cordia New\"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US;} .MsoPapDefault {mso-style-type:export-only; margin-bottom:8.0pt; line-height:115%;} @page WordSection1 {size:612.0pt 792.0pt; margin:72.0pt 72.0pt 72.0pt 72.0pt; mso-header-margin:36.0pt; mso-footer-margin:36.0pt; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} \/* List Definitions *\/ @list l0 {mso-list-id:357896632; mso-list-template-ids:180109484;} @list l0:level1 {mso-level-number-format:bullet; mso-level-text:\uf0b7; mso-level-tab-stop:36.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Symbol;} @list l0:level2 {mso-level-number-format:bullet; mso-level-text:o; mso-level-tab-stop:72.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:\"Courier New\"; mso-bidi-font-family:\"Times New Roman\";} @list l0:level3 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:108.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level4 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:144.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level5 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:180.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level6 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:216.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level7 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:252.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level8 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:288.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} @list l0:level9 {mso-level-number-format:bullet; mso-level-text:\uf0a7; mso-level-tab-stop:324.0pt; mso-level-number-position:left; text-indent:-18.0pt; mso-ansi-font-size:10.0pt; font-family:Wingdings;} --><br \/><\/style><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">Challenges in Software Development<\/span><\/b><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">Common challenges in medical software projects include:<\/span><\/p><ul style=\"margin-bottom: 0cm; caret-color: #000000; color: #000000; margin-top: 0cm;\" type=\"disc\"><li><b><span lang=\"EN-US\">Delayed delivery<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Budget overruns<\/span><\/b><\/li><li><b><span lang=\"EN-US\">Low-quality or unsafe software<\/span><\/b><\/li><li><b><span lang=\"EN-US\">User dissatisfaction<\/span><\/b><\/li><\/ul><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">To overcome these, organizations increasingly apply\u00a0<b>Software Engineering principles<\/b>\u00a0\u2014 structured methodologies, tools, and processes that bring consistency and accountability to software development. These help ensure that software meets quality requirements, stays within budget, and delivers on schedule.<\/span><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><span lang=\"EN-US\">Ultimately, achieving the desired level of software quality relies on robust\u00a0<b>Software Quality Management<\/b>\u00a0\u2014 the focus of\u00a0<b>Part 2<\/b>\u00a0in this series.<\/span><\/p><div style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000; text-align: center;\" align=\"center\"><hr align=\"center\" size=\"0\" width=\"100%\" \/><\/div><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">Coming Next:<\/span><\/b><\/p><p style=\"line-height: 18.4px; font-size: medium; caret-color: #000000; color: #000000;\"><b><span lang=\"EN-US\">Part 2 \u2013 Software Quality Management and Compliance with IEC 62304<\/span><\/b><\/p><\/div><p><strong style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: 1.125rem;\">Author : Panita Meananeatra<\/strong><\/p><p>Cover Picture : https:\/\/bit.ly\/3tNrlHJ<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0Ensuring Safety and Reliability Through International Standards Medical devices and medical device software play a crucial role in modern healthcare &hellip; <\/p>\n","protected":false},"author":2,"featured_media":3538,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[215],"tags":[225,228,227,226,239],"table_tags":[],"class_list":["post-3523","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-awarenessarticle","tag-medical-device","tag-software-validation","tag-software-verification","tag-software-verification-and-validation","tag-239"],"_links":{"self":[{"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/posts\/3523","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/comments?post=3523"}],"version-history":[{"count":30,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/posts\/3523\/revisions"}],"predecessor-version":[{"id":4968,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/posts\/3523\/revisions\/4968"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/media\/3538"}],"wp:attachment":[{"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/media?parent=3523"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/categories?post=3523"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/tags?post=3523"},{"taxonomy":"table_tags","embeddable":true,"href":"https:\/\/www.squat.in.th\/en\/wp-json\/wp\/v2\/table_tags?post=3523"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}