{"id":403406,"date":"2024-10-20T05:05:58","date_gmt":"2024-10-20T05:05:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-72008a12022-tc\/"},"modified":"2024-10-26T09:05:32","modified_gmt":"2024-10-26T09:05:32","slug":"bs-en-iso-10993-72008a12022-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-72008a12022-tc\/","title":{"rendered":"BS EN ISO 10993-7:2008+A1:2022 – TC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\n30455191 <\/td>\n<\/tr>\n
149<\/td>\nA-30355037 <\/td>\n<\/tr>\n
150<\/td>\nNational foreword <\/td>\n<\/tr>\n
154<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
155<\/td>\nAnnex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93\/42\/EEC Medical devices <\/td>\n<\/tr>\n
156<\/td>\nAnnex ZB (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 90\/385\/EEC on Active Implantable Medical Devices <\/td>\n<\/tr>\n
158<\/td>\nForeword <\/td>\n<\/tr>\n
159<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
160<\/td>\n4 Requirements
4.1 General
4.2 Categorization of devices <\/td>\n<\/tr>\n
161<\/td>\n4.3 Allowable limits
4.3.1 General
4.3.2 Permanent contact devices
4.3.3 Prolonged exposure devices <\/td>\n<\/tr>\n
162<\/td>\n4.3.4 Limited exposure devices
4.3.5 Tolerable contact limits for surface contacting devices and implants
4.3.6 Special situations <\/td>\n<\/tr>\n
163<\/td>\n4.4 Determination of EO and ECH residuals
4.4.1 General
4.4.2 Determination of residue <\/td>\n<\/tr>\n
164<\/td>\n4.4.3 Product sampling and sample \u201cblank\u201d <\/td>\n<\/tr>\n
165<\/td>\n4.4.4 Sample\/fluid ratios
4.4.5 Extraction time and conditions
4.4.6 Product extraction <\/td>\n<\/tr>\n
167<\/td>\n4.4.7 Data analysis and interpretation <\/td>\n<\/tr>\n
168<\/td>\n5 Product release
5.1 General
5.2 Release of products without dissipation curve data
5.3 Procedure for product release using residue dissipation curves <\/td>\n<\/tr>\n
170<\/td>\nBibliography <\/td>\n<\/tr>\n
182<\/td>\nAnnex A (normative) Evaluation of gas chromatograms <\/td>\n<\/tr>\n
185<\/td>\nAnnex B (informative) Gas chromatographic determination for EO and ECH <\/td>\n<\/tr>\n
189<\/td>\nAnnex C (informative) Flowchart and guidance for the application of this part of ISO 10993 series of standards to the determination of EO and ECH residuals in medical devices <\/td>\n<\/tr>\n
196<\/td>\nAnnex D (informative) Factors influencing product residual <\/td>\n<\/tr>\n
198<\/td>\nAnnex E (informative) Extraction conditions for determination of residual EO <\/td>\n<\/tr>\n
199<\/td>\nAnnex F (informative) Rationale for the provisions of this part of ISO 10993 <\/td>\n<\/tr>\n
203<\/td>\nAnnex G (informative) Establishment of allowable limits for EO <\/td>\n<\/tr>\n
220<\/td>\nAnnex H (informative) Establishment of allowable limits for ECH <\/td>\n<\/tr>\n
229<\/td>\nAnnex I (informative) Establishment of allowable limits for EG <\/td>\n<\/tr>\n
233<\/td>\nAnnex J (informative) Preparation of EO and ECH standards <\/td>\n<\/tr>\n
237<\/td>\nAnnex K (informative) Ethylene oxide residue measuring methods <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Biological evaluation of medical devices – Ethylene oxide sterilization residuals<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n246<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":403413,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-403406","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/403406","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/403413"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=403406"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=403406"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=403406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}