{"id":402305,"date":"2024-10-20T05:00:32","date_gmt":"2024-10-20T05:00:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-254242019a12022\/"},"modified":"2024-10-26T08:54:02","modified_gmt":"2024-10-26T08:54:02","slug":"bs-en-iso-254242019a12022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-254242019a12022\/","title":{"rendered":"BS EN ISO 25424:2019+A1:2022"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZA (informative) \uea01Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered
Annex ZA (informative) \uea01Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
10<\/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
Annex 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
15<\/td>\nForeword <\/td>\n<\/tr>\n
16<\/td>\nIntroduction <\/td>\n<\/tr>\n
19<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
20<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
26<\/td>\n4 Quality management system elements
4.1 General
4.2 Documentation
4.3 Management responsibility <\/td>\n<\/tr>\n
27<\/td>\n4.4 Product realization
4.5 Control of non-conforming product
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness <\/td>\n<\/tr>\n
28<\/td>\n5.4 Material effects
5.5 Environmental considerations
6 Process and equipment characterization
6.1 General
6.2 Process <\/td>\n<\/tr>\n
29<\/td>\n6.3 Equipment
7 Product definition <\/td>\n<\/tr>\n
30<\/td>\n8 Process definition <\/td>\n<\/tr>\n
31<\/td>\n9 Validation
9.1 General <\/td>\n<\/tr>\n
32<\/td>\n9.2 Installation qualification
9.2.1 General
9.2.2 Installation
9.2.3 Equipment <\/td>\n<\/tr>\n
33<\/td>\n9.3 Operational qualification
9.4 Performance qualification
9.4.1 General <\/td>\n<\/tr>\n
34<\/td>\n9.4.2 Performance qualification \u2014 Physical
9.4.3 Performance qualification \u2014 Microbiological <\/td>\n<\/tr>\n
35<\/td>\n9.4.4 Performance qualification \u2014 Desorption and drying
9.5 Review and approval of validation <\/td>\n<\/tr>\n
36<\/td>\n10 Routine monitoring and control
10.1 General
10.2 Biological indicators
10.3 Chemical indicators
10.4 Records <\/td>\n<\/tr>\n
37<\/td>\n11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification <\/td>\n<\/tr>\n
38<\/td>\n12.4 Assessment of change <\/td>\n<\/tr>\n
39<\/td>\nAnnex A (normative) Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilized <\/td>\n<\/tr>\n
40<\/td>\nAnnex B (normative) Process definition based on inactivation of reference microorganisms <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Guidance on application of this document <\/td>\n<\/tr>\n
53<\/td>\nAnnex D (informative) Environmental aspects regarding development, validation and routine control of low temperature steam and formaldehyde processes <\/td>\n<\/tr>\n
58<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for 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>\n2022<\/td>\n60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":402312,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-402305","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\/402305","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\/402312"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=402305"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=402305"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=402305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}