{"id":453387,"date":"2024-10-20T09:29:59","date_gmt":"2024-10-20T09:29:59","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11737-1-2018-a1-2021\/"},"modified":"2024-10-26T17:37:33","modified_gmt":"2024-10-26T17:37:33","slug":"aami-11737-1-2018-a1-2021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11737-1-2018-a1-2021\/","title":{"rendered":"AAMI 11737 1 2018 A1 2021"},"content":{"rendered":"
ISO 11737-1:2018 was developed to specify general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material, or packaging. This amendment expands on general information relating to the development, validation, and routine control of a sterilization process. It also adds a requirement for calibration of all equipment used to meet requirements. This amendment updates the method for calculating the most probable number.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | ANSI\/AAMI\/ISO 11737-1:2018\/A1:2021; Sterilization of health care products\u2014Microbiological methods\u2014Part 1: Determination of a population of microorganisms on products, AMENDMENT 1 <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Background of ANSI\/AAMI adoption of ISO 11737-1:2018\/A1:2021 <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | ANSI\/AAMI\/ISO 11737-1:2018\/A1:2021 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 11737-1:2018\/A1:2021 Sterilization of health care products\u2014Microbiological methods\u2014Part 1: Determination of a population of microorganisms on products\u2014AMENDMENT 1<\/b><\/p>\n |