GB/T 31995-2015Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose method VDmax (English PDF)
医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
September 11, 2015
Implementation date
April 1, 2016
Scope
GB/T 31995-2015 is the English-translated version of 医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法.
GB/T 31995-2015 is the Chinese standard "Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose method VDmax".
Its scope clause reads: This standard specifies the radiation sterilization of health care products to make a sterility assurance level of 10-6 selected sterilization dose and dose confirmation Audit methods.
This standard applies to the entire product unit, in line with the average bioburden average bioburden range of selected doses required for medical care product. Its clauses include terms and definitions.
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Document preview — GB/T 31995-2015
National Standard of the People's Republic of China
- ICS
- 27.120.99
- Classification
- F 54
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 5 Development and validation of the sterilization dose in the choice of products and experiment
- 6 VDmax method - confirm selected sterilization dose
- 7 sterilization dose audit
- 8 Use VDmax proven method to increase the sterilization dose of
- 9 Working Example
- Appendix A (informative) verification dose, SIP dose reduction factor, VDmaxSD dose of added value lookup table
1 Scope
This standard specifies the radiation sterilization of health care products to make a sterility assurance level of 10-6 selected sterilization dose and dose confirmation
Audit methods.
This standard applies to the entire product unit, in line with the average bioburden average bioburden range of selected doses required for medical care product.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 18280.1-2015 Radiation Sterilization of health care products - Part 1. Development of medical equipment sterilization process, validation and routine
Control requirements
GB 18280.2-2015 Sterilization of health care products - Radiation - Part 2. Establish sterilization dose
GB/T 18280.3-2015 Radiation Sterilization of health care products - Part 3. Dose Measurement Guide
Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms
Learn sterilization methods - Part 2 microorganisms GB/T 19973.2 medical devices. sterility test confirmed the sterilization process
Requirements YY/T 0287 medical device quality management system for regulatory
3 Terms and Definitions
GB 18280.1-2015, GB 18280.2-2015 and GB/T 18280.3-2015 and as defined in the following terms and definitions apply
In this document.
3.1 Medical Devices
The human body is designed to achieve the following intended purpose of the apparatus, equipment, apparatus, in vitro diagnostic reagents and calibrators, and other similar materials or
Related items, including computer software required.
--- Disease diagnosis, prevention, monitoring, treatment or mitigation;
--- Injury diagnosis, monitoring, treatment, mitigation or compensation;
--- Physical structure or physiological process of inspection, replacement, or adjustment support;
--- Support or sustain life;
--- Control of conception;
--- Disinfection or sterilization of medical devices;
--- Based on a sample from the body for inspection, provide information for medical or diagnostic purposes.
NOTE. Medical Devices, mainly through acoustic, optical, electrical and other physical get in the way, not by pharmacological, immunological or metabolic get in the way, though, or
However, there are ways to participate, but these only play a supporting role.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 38 pages — is available in the English PDF.
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