{"id":409061,"date":"2024-10-20T05:33:46","date_gmt":"2024-10-20T05:33:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-224412022\/"},"modified":"2024-10-26T10:11:02","modified_gmt":"2024-10-26T10:11:02","slug":"bs-iso-224412022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-224412022\/","title":{"rendered":"BS ISO 22441:2022"},"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\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
12<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4 Quality management system elements <\/td>\n<\/tr>\n
21<\/td>\n5 Sterilizing agent characterization
5.1 General
5.2 Sterilant and sterilizing agent
5.3 Microbicidal effectiveness <\/td>\n<\/tr>\n
22<\/td>\n5.4 Effects on materials
5.5 Safety and the environment <\/td>\n<\/tr>\n
23<\/td>\n6 Process and equipment characterization
6.1 General
6.2 Process characterization <\/td>\n<\/tr>\n
24<\/td>\n6.3 Equipment characterization <\/td>\n<\/tr>\n
25<\/td>\n7 Product definition <\/td>\n<\/tr>\n
26<\/td>\n8 Process definition <\/td>\n<\/tr>\n
27<\/td>\n9 Validation
9.1 General <\/td>\n<\/tr>\n
28<\/td>\n9.2 Installation qualification (IQ)
9.2.1 General
9.2.2 Equipment <\/td>\n<\/tr>\n
29<\/td>\n9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
31<\/td>\n9.5 Review and approval of validation
10 Routine monitoring and control <\/td>\n<\/tr>\n
32<\/td>\n11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Recalibration
12.3 Maintenance of equipment <\/td>\n<\/tr>\n
33<\/td>\n12.4 Requalification
12.5 Assessment of change <\/td>\n<\/tr>\n
34<\/td>\nAnnex A (normative) Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness <\/td>\n<\/tr>\n
36<\/td>\nAnnex B (normative) Approach 1 \u2014 Process definition based on inactivation of the microbial population in its natural state (bioburden method) <\/td>\n<\/tr>\n
38<\/td>\nAnnex C (normative) Approach 2 \u2014 Process definition based on inactivation of reference microorganisms and knowledge of bioburden (BI\/bioburden method) <\/td>\n<\/tr>\n
40<\/td>\nAnnex D (normative) Approach 3 \u2014 Conservative process definition based on inactivation of reference microorganisms (overkill method) <\/td>\n<\/tr>\n
43<\/td>\nAnnex E (informative) Guidance on application of this document <\/td>\n<\/tr>\n
66<\/td>\nAnnex F (informative) Schematic example of a VH2O2 sterilization cycle <\/td>\n<\/tr>\n
67<\/td>\nAnnex G (informative) Environmental aspects <\/td>\n<\/tr>\n
72<\/td>\nAnnex H (informative) Justification for the number of temperature sensors and biological indicators (BIs) <\/td>\n<\/tr>\n
74<\/td>\nAnnex I (informative) Aspects of VH2O2 <\/td>\n<\/tr>\n
77<\/td>\nAnnex J (informative) Recommended validation tests <\/td>\n<\/tr>\n
82<\/td>\nAnnex K (informative) Recommended validation test procedures <\/td>\n<\/tr>\n
88<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products. Low temperature vaporized hydrogen peroxide. 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>\n2022<\/td>\n90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":409070,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-409061","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\/409061","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\/409070"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=409061"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=409061"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=409061"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}