GB 27955-2011 (English Version) PDF

Standard No.: GB 27955-2011
Language: Chinese, Available in English version
Release Date: 2011
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status: Be replaced 2020-11
Replace By: GB 27955-2020
Latest: GB 27955-2020

Scope: This standard specifies the naming, technical requirements, inspection methods, scope of use, labels, identification, packaging, product labels and instructions for use of hydrogen peroxide gas plasma low temperature sterilization devices. This standard applies to hydrogen peroxide gas plasma low-temperature sterilization devices for medical device sterilization.

GB 27955-2011 Referenced Document

GB 18281.1 Sterilization of health care products.Biological indicators.Part 1:General requirements*， 2015-12-10 Update
GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 19972 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results*， 2018-03-15 Update
GBZ 2.1 "Occupational Exposure Limits of Hazardous Factors in the Workplace Part 1: Chemical Hazardous Factors" (GBZ 2.1-2019) No. 1 Amendment*， 2022-11-08 Update

2020 GB 27955-2020 Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer
2011 GB 27955-2011 General requirements for low-temperature hydrogen peroxide gas plasma sterilizer