{"id":408968,"date":"2024-10-20T05:33:19","date_gmt":"2024-10-20T05:33:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30409085-dc-2022\/"},"modified":"2024-10-26T10:09:48","modified_gmt":"2024-10-26T10:09:48","slug":"bsi-22-30409085-dc-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30409085-dc-2022\/","title":{"rendered":"BSI 22\/30409085 DC 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
1<\/td>\n30409835-NC.pdf <\/td>\n<\/tr>\n
3<\/td>\nISO_DIS 17665 ed.2 – id.80271 Enquiry PDF (en).pdf <\/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
22<\/td>\n4 General <\/td>\n<\/tr>\n
23<\/td>\n5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Effects on materials
5.4 Environmental consideration <\/td>\n<\/tr>\n
24<\/td>\n6 Process and equipment characterization
6.1 General
6.2 Process characterization <\/td>\n<\/tr>\n
25<\/td>\n6.3 Saturated steam sterilization processes <\/td>\n<\/tr>\n
26<\/td>\n6.4 Contained product sterilization processes
6.5 Equipment <\/td>\n<\/tr>\n
28<\/td>\n7 Product definition <\/td>\n<\/tr>\n
29<\/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 (IQ) <\/td>\n<\/tr>\n
33<\/td>\n9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
35<\/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
36<\/td>\n10.3 Process success verification
10.4 Evaluation of additional data for saturated steam sterilization processes <\/td>\n<\/tr>\n
37<\/td>\n10.5 Evaluation of additional data for sterilization processes for contained product
10.6 Record retention
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Purpose
12.2 Demonstration of continued effectiveness <\/td>\n<\/tr>\n
38<\/td>\n12.3 Recalibration
12.4 Equipment maintenance
12.5 Requalification <\/td>\n<\/tr>\n
39<\/td>\n12.6 Assessment of change <\/td>\n<\/tr>\n
40<\/td>\nAnnex\u20acA (informative) Guidance on the principles of moist heat sterilization and rationales for requirements <\/td>\n<\/tr>\n
69<\/td>\nAnnex\u20acB (informative) Establishment and evaluation of a sterilization process primarily based on microbiological inactivation <\/td>\n<\/tr>\n
82<\/td>\nAnnex\u20acC (informative) Establishing a sterilization process primarily based on the measurement of physical parameters <\/td>\n<\/tr>\n
91<\/td>\nAnnex\u20acD (informative) Operating cycles <\/td>\n<\/tr>\n
97<\/td>\nAnnex\u20acE (informative) Temperature and pressure of saturated steam for use in moist heat sterilization <\/td>\n<\/tr>\n
102<\/td>\nAnnex\u20acF (informative) Guidance on the application of normative requirements in health care facility settings <\/td>\n<\/tr>\n
126<\/td>\nAnnex\u20acG (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
133<\/td>\nAnnex\u20acH (informative) Guidance on the application of the normative requirements in the industrial setting <\/td>\n<\/tr>\n
158<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN ISO 17665. 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>\n2022<\/td>\n161<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408975,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-408968","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/408968","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\/408975"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408968"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408968"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408968"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}