{"id":2138,"date":"2024-11-07T10:48:25","date_gmt":"2024-11-07T02:48:25","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2138"},"modified":"2025-12-05T10:47:35","modified_gmt":"2025-12-05T02:47:35","slug":"eto-sterilization-chamber-testing","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2138","title":{"rendered":"ETO Sterilization Chamber Testing"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-b98f6ad4 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ETO-STERILIZER-FAT-225x300.webp\" alt=\"\" class=\"uag-image-8380\" width=\"225\" height=\"300\" title=\"ETO-STERILIZER-FAT\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-temperature-and-humidity-distribution-testing\">Temperatura ug Humidity Distribution Testing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer&#8217;s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-surface-temperature-test-of-eto-sterilization-chamber\">a) Internal Surface Temperature Test sa ETO Sterilization Chamber:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atol sa pagsulay, ang sterilization chamber kinahanglan nga walay sulod, apan ang mga auxiliary device nga gikinahanglan alang sa sterilization mahimong ma-install. Ang pultahan sa sterilization chamber kinahanglan nga sirado.<\/li>\n\n\n\n<li>The temperature of any preheating stage as specified by the sterilizer manufacturer should be recorded. The temperature of all internal surfaces of the sterilization chamber should not exceed the set temperature of the sterilization phase by \u00b15\u00b0C.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-temperature-and-humidity-test-in-the-eto-sterilization-chamber\">b) Temperature ug Humidity Test sa ETO Sterilization Chamber:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atol sa pagsulay, ang ETO Sterilization Chamber kinahanglan nga walay sulod, apan ang mga auxiliary device nga gikinahanglan alang sa sterilization mahimong ma-install. Ang pultahan sa sterilization chamber kinahanglan nga sirado.<\/li>\n\n\n\n<li>Gamita ang mga sensor sa temperatura ug humidity nga gibutang sa espesipikong mga posisyon aron itandi sa pagkontrol sa temperatura sulod sa lawak. Ang mga sensor sa temperatura kinahanglan ibutang sa mga lokasyon nga lagmit nagrepresentar sa labing taas nga mga kalainan sa temperatura, sama sa wala pa init nga mga bahin sa lawak, duol sa mga pultahan sa kabinete, ug duol sa alisngaw o gas entry point. Ang ubang mga sensor kinahanglan nga parehas nga ipang-apod-apod sa tibuuk nga magamit nga gidaghanon sa kwarto sa sterilization, lakip ang tunga, taas, ubos, atubangan, ug likod. Ang gidaghanon sa mga sensor kinahanglan nga makatagbo sa mga kinahanglanon sa Apendise C sa GB18279.1.<\/li>\n\n\n\n<li>Ang posisyon sa matag sukod kinahanglan nga irekord, ug ang temperatura ug humidity sa lain-laing mga dapit sa sterilization lawak kinahanglan nga natala aron sa pag-ila sa mga potensyal nga hot spots ug bugnaw nga mga spots.<\/li>\n\n\n\n<li>The indoor temperature range of the sterilization chamber when empty should not exceed \u00b12\u00b0C of the set temperature or \u00b13\u00b0C of the average temperature inside the chamber.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-vacuum-pumping-rate\">Vacuum Pumping Rate<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ang vacuum system sa panahon sa vacuum pumping phase kinahanglan nga makahimo sa pagbakwit sa walay sulod nga sterilization chamber ngadto sa -75 kPa o ubos pa. Ang pressure gauge kinahanglan nga konektado sa vacuum test inlet aron maobserbahan kung nakab-ot ba kini sa gikinahanglan nga sumbanan.<\/li>\n\n\n\n<li>Kinahanglang kumpirmahon sa tiggama ang oras nga gikinahanglan aron makaabot sa -50 kPa ug -75 kPa sa ilawom sa mga kondisyon sa pagkarga nga walay sulod. Ang usa ka timing device mahimong magamit sa pagmonitor sa vacuum pumping phase, ug ang preset parameters kinahanglang maabot sulod sa gitakdang oras.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-leakage-test\"> ETO Sterilization Cabinet Leakage Test<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ang ETO Sterilization Cabinet leakage test naglakip sa vacuum (negative pressure) leakage testing ug pressure (positive pressure) leakage testing (kung mahimo). Kung ang presyur sa pagtrabaho sa sterilizer labi pa sa 5 kPa, kinahanglan nga himuon ang usa ka pagsulay (positibo nga presyur) nga pagtulo.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The vacuum leakage test should be conducted before the sterilant injection phase and the humidification phase, with the testing method following the provisions of Appendix D.1 of YY0503. The preset pressure during the test should be less than -20 kPa and at least 20 kPa lower than the preset sterilization pressure. Once the preset pressure is reached, all valves connected to the sterilization chamber should be closed, and the vacuum pump should stop working. The pressure in the sterilization chamber should be monitored, and the pressure rise within 5 minutes should not exceed 0.3 kPa\/min. The pressure variation during the entire test should not exceed 0.1 kPa\/min.<\/li>\n\n\n\n<li>Positive pressure leakage testing (if applicable) should be conducted before the vacuum pumping phase. The preset pressure for the test should be within 10% of the sterilizer&#8217;s preset working pressure. The pressure drop within 5 minutes should not exceed 0.3 kPa\/min. At the same time, according to the method in Appendix D.2 of YY0503, the sterilization time should be set to at least 65 minutes, using inert gas (such as air) to replace EO gas and run a normal sterilization cycle. After the sterilization phase reaches temperature stability for 2 minutes, the pressure in the sterilization chamber should be recorded. It should be recorded again after 60 minutes \u00b1 1 minute. The pressure variation rate should not exceed 0.1 kPa\/min.Auxiliary System Verification<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">During the operational verification, the performance of related auxiliary systems should be confirmed, including but not limited to: the quality of steam provided, the ability of the EO vaporizer to reach the minimum gas input temperature, the reliability of the sterilizer\u2019s air filtration and water supply systems, and the ability of the steam generator to maintain the required supply quality under maximum sterilization load conditions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Examples of acceptable auxiliary system performance: a) When steam is injected during the processing phase, the humidity in the sterilization chamber should show a noticeable change, and the chamber should maintain pressure within \u00b12.5 kPa of the set pressure. b) The temperature of the injected EO gas should be higher than the minimum value set for the vaporizer (usually 10.7\u00b0C at atmospheric pressure) to ensure that the EO injected is in gaseous form, not liquid. c) The filtration effectiveness of the air filtration system should meet the requirement of a filtration rate of at least 99.5% for particles greater than 0.3 microns. d) The water supply system should use purified water meeting the requirements of the 2020 edition of the Chinese Pharmacopoeia. e) The steam vapor pressure used for humidification in the sterilizer should not exceed 50 kPa.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-software\"> ETO Sterilization Cabinet Software<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Atol sa proseso sa sterilization, ang sterilization equipment software magkontrol ug magmonitor sa proseso sa sterilization ug magtimbang-timbang sa mga parameter sa sterilization cycle. Busa, sa panahon sa proseso sa kwalipikasyon sa operasyon, ang software sa kagamitan sa sterilization kinahanglan nga sulayan sa ilawom sa tanan nga mga kahimtang sa kapakyasan (sama sa computerized nga pagsukod ug mga sistema sa pagkontrol). Tan-awa ang manwal sa paggamit sa sterilizer ug mga detalye sa kagamitan, ug sulayi ang mga gimbuhaton sa sistema sa software sa mga lugar sama sa pagdumala sa alarma, pagproseso sa sayup, pagdumala sa kasayuran, mga setting sa parameter, mga interface sa rekord sa kasaysayan, pagkontrol ug pagmonitor sa sensor, ug pagkontrol ug pagmonitor sa operasyon sa ilawom sa mga kondisyon nga naghagit sa mga limitasyon sa operasyon sa kagamitan.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">Kung gusto nimo mahibal-an ang dugang bahin sa ethylene Oxide Sterilisasyon<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telepono:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lokal nga Dapit: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Website:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Mga pakisayran<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:11135:ed-2:v1:en\">ISO 11135:2014&nbsp;Sterilization of health-care products \u2014 Ethylene oxide \u2014 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/mpa.ah.gov.cn\/group5\/M00\/06\/C0\/wKg8v2VfBqaAY-YsABTsjWADtvQ314.pdf\">Anhui Province medical device ethylene oxide sterilization confirmation work guide<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer&#8217;s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.<\/p>\n","protected":false},"author":234312599,"featured_media":8493,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2138","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ETO Sterilization Chamber Testing - ETO STERILIZER<\/title>\n<meta name=\"description\" content=\"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. 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It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-yu","jetpack-related-posts":[{"id":2448,"url":"https:\/\/zjbocon.com\/?p=2448","url_meta":{"origin":2138,"position":0},"title":"eto sterilization Chamber Temperature Distribution Testing","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company 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Team","date":"2024-12-24","format":false,"excerpt":"3.4.1 eto sterilizer machine Temperature Setting Range The temperature setting range for the eto sterilizer is: 30 to 70\u00b0C","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":1659,"url":"https:\/\/zjbocon.com\/?p=1659","url_meta":{"origin":2138,"position":2},"title":"Comparing ETO, Gamma, and Steam Sterilization for Spices","author":"Bocon Technical Team","date":"2024-10-21","format":false,"excerpt":"advantage:\u00a0This\u00a0is\u00a0a\u00a0cost-effective,\u00a0widely-used\u00a0sterilization\u00a0method\u00a0that\u00a0has\u00a0been\u00a0common\u00a0for\u00a0many\u00a0years, when you buy the machine, you can sterilize by yourself, and the cost is very cheap.large volume (1-36pallet) (around 1-35ton spice one time, depending on the density Of spice ) disadvantage:\u00a0ETO\u00a0is\u00a0a\u00a0heavily-regulated, gas.\u00a0And\u00a0will\u00a0take\u00a0more\u00a0time\u00a0than\u00a0the other\u00a0two\u00a0sterilization\u00a0way(you can install a pre-heating room and aeration room to solve this problem).","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO 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https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/advantage-and-disadvantage-between-eto-sterilization-irradiation-and-steam-in-spice-sterilization-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2138,"position":3},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":1989,"url":"https:\/\/zjbocon.com\/?p=1989","url_meta":{"origin":2138,"position":4},"title":"The Detail Of EtO Sterilization Cycle\u00a0","author":"Bocon Technical Team","date":"2024-10-25","format":false,"excerpt":"The Detail EtO Sterilization Cycle\u00a0 A typical EtO sterilization cycle comprises three main stages: Preconditioning This stage prepares the chamber to create optimal conditions for temperature, pressure, and humidity. \u00a0First, air is evacuated to enhance gas penetration, followed by a leakage test to ensure safety for personnel and the environment.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO 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Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2138","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2138"}],"version-history":[{"count":6,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2138\/revisions"}],"predecessor-version":[{"id":8878,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2138\/revisions\/8878"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8493"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2138"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2138"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}