{"id":457411,"date":"2024-10-20T09:51:02","date_gmt":"2024-10-20T09:51:02","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-176652024\/"},"modified":"2024-10-26T18:18:22","modified_gmt":"2024-10-26T18:18:22","slug":"bs-en-iso-176652024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-176652024\/","title":{"rendered":"BS EN ISO 17665:2024"},"content":{"rendered":"

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.<\/p>\n

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\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
7<\/td>\nAnnex ZA (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
12<\/td>\nAnnex ZB (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/746 aimed to be covered <\/td>\n<\/tr>\n
17<\/td>\nForeword <\/td>\n<\/tr>\n
18<\/td>\nIntroduction <\/td>\n<\/tr>\n
21<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
22<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
32<\/td>\n4 General <\/td>\n<\/tr>\n
33<\/td>\n5 Sterilizing agent characterization
5.1 Sterilizing agent <\/td>\n<\/tr>\n
34<\/td>\n5.2 Microbicidal effectiveness
5.3 Effects on materials
5.4 Environmental consideration
6 Process and equipment characterization
6.1 General
6.2 Process characterization <\/td>\n<\/tr>\n
35<\/td>\n6.3 Saturated steam sterilization processes <\/td>\n<\/tr>\n
36<\/td>\n6.4 Contained product sterilization processes <\/td>\n<\/tr>\n
37<\/td>\n6.5 Equipment <\/td>\n<\/tr>\n
38<\/td>\n7 Product definition <\/td>\n<\/tr>\n
40<\/td>\n8 Process definition <\/td>\n<\/tr>\n
42<\/td>\n9 Validation
9.1 General <\/td>\n<\/tr>\n
43<\/td>\n9.2 Installation qualification (IQ)
9.3 Operational qualification (OQ) <\/td>\n<\/tr>\n
44<\/td>\n9.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
46<\/td>\n9.5 Review and approval of validation
10 Routine monitoring and control
10.1 Routine monitoring
10.2 Operational status <\/td>\n<\/tr>\n
47<\/td>\n10.3 Process verification
10.4 Evaluation of additional data for saturated steam sterilization processes
10.5 Evaluation of additional data for contained product sterilization processes. <\/td>\n<\/tr>\n
48<\/td>\n10.6 Record retention
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Purpose
12.2 Demonstration of continued effectiveness <\/td>\n<\/tr>\n
49<\/td>\n12.3 Recalibration
12.4 Equipment maintenance
12.5 Requalification <\/td>\n<\/tr>\n
50<\/td>\n12.6 Assessment of change <\/td>\n<\/tr>\n
51<\/td>\nAnnex A (informative) Guidance on the principles of moist heat sterilization and rationales for requirements <\/td>\n<\/tr>\n
79<\/td>\nAnnex B (informative) Establishment and evaluation of a sterilization process primarily based on microbiological inactivation <\/td>\n<\/tr>\n
93<\/td>\nAnnex C (informative) Establishment and evaluation of a sterilization process primarily based on the measurement of physical parameters <\/td>\n<\/tr>\n
103<\/td>\nAnnex D (informative) Examples of moist heat sterilization cycles <\/td>\n<\/tr>\n
109<\/td>\nAnnex E (informative) Temperature and pressure of saturated steam for use in moist heat sterilization <\/td>\n<\/tr>\n
113<\/td>\nAnnex F (informative) Guidance on the application of the normative requirements in health care facilities <\/td>\n<\/tr>\n
138<\/td>\nAnnex G (informative) Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat <\/td>\n<\/tr>\n
146<\/td>\nAnnex H (informative) Guidance on the application of the normative requirements in industrial settings <\/td>\n<\/tr>\n
170<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2024<\/td>\n176<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":457421,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-457411","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","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\/457411","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\/457421"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=457411"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=457411"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=457411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}