11.080.01 消毒和灭菌综合 标准查询与下载



共找到 871 条与 消毒和灭菌综合 相关的标准,共 59

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ICS
11.080.01
CCS
发布
2021-12-28
实施

Aseptic processing of health care products —Part 2: Sterilizing filtration

ICS
11.080.01
CCS
发布
2021-12-28
实施

BS EN ISO 13408-1. Aseptic processing of health care products - Part 1. General requirements

ICS
11.080.01
CCS
发布
2021-12-17
实施
2021-12-17

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

ICS
11.080.01
CCS
C05
发布
2021-11-01
实施

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

ICS
11.080.01
CCS
发布
2021-11-01
实施
2021-11-01

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes in

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021

ICS
11.080.01
CCS
C47
发布
2021-11-00
实施

This part of ISO 13408 specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell base

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021

ICS
11.080.01
CCS
发布
2021-11-00
实施

This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021); German version EN ISO 11138-8:2021

ICS
11.080.01
CCS
发布
2021-11-00
实施

Dental impression and model disinfection management practices

ICS
11.080.01
CCS
C05
发布
2021-10-29
实施
2022-02-01

Disinfection Hygienic Specifications for Residential Areas

ICS
11.080.01
CCS
C 51
发布
2021-10-27
实施
2021-12-01

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

ICS
11.080.01
CCS
发布
2021-10-21
实施
2021-10-21

Aseptic processing of health care products - Part 6: Isolator systems

ICS
11.080.01
CCS
发布
2021-10-21
实施
2021-10-21

Aseptic processing of health care products -- Part 6: Isolator systems (ISO 13408-6:2021)

ICS
11.080.01
CCS
发布
2021-10-20
实施
2021-10-20

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

ICS
11.080.01
CCS
发布
2021-10-15
实施
2021-10-15

Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices -- Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018

ICS
11.080.01
CCS
发布
2021-10-15
实施
2021-10-15

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

ICS
11.080.01
CCS
发布
2021-10-15
实施
2021-10-15

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

ICS
11.080.01
CCS
发布
2021-10-15
实施
2021-10-15

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

ICS
11.080.01
CCS
发布
2021-10-00
实施
2021-10-01

1  范围  2  规范性引用文件  3  术语和定义  4  要求  5  消毒原则  6  消毒剂选择与使用  7  消毒方式  8  消毒方法  9  消毒效果评价 

Technical specifications for the prevention and control of respiratory infectious diseases in automobile showrooms

ICS
11.080.01
CCS
O811
发布
2021-09-16
实施
2022-08-04

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

ICS
11.080.01
CCS
发布
2021-09-15
实施
2021-09-15



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