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GB 18278.1-2015   Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices (English Version)
Standard No.: GB 18278.1-2015 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 18500 words Price(USD):140.0 remind me the price change

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Implemented on:2017-1-1 Delivery: via email in 1~3 business day
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Standard No.: GB 18278.1-2015
English Name: Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
Chinese Name: 医疗保健产品灭菌 湿热 第1部分:医疗器械灭菌过程的开发、确认和常规控制要求
Chinese Classification: C47    Public medical equipment
Professional Classification: GB    National Standard
ICS Classification: 11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Issued by: AQSIQ; SAC
Issued on: 2015-12-10
Implemented on: 2017-1-1
Status: valid
Superseding:GB 18278-2000 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
GB/T 20376-2006 Modified starch - Determination ofhydroxypropyl content - Method using proton nuclear magnetic resonance (NMR) spectrometry
GB/T 20367-2006 Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities
Language: English
File Format: PDF
Word Count: 18500 words
Price(USD): 140.0
Delivery: via email in 1~3 business day
GB 18278.1-2015 is referred in:
*GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
*GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use
*YY 0585.2-2019 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 2:Accessories
*YY/T 0286.4-2020 Special infusion sets—Part 4:Infusion sets for single use with pressure infusion apparatus
*YY 0861-2024 Ophthalmic optics—Ophthalmic viscosurgical devices
*GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1: General requirements
Code of China
Standard
GB 18278.1-2015  Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices (English Version)
Standard No.GB 18278.1-2015
Statusvalid
LanguageEnglish
File FormatPDF
Word Count18500 words
Price(USD)140.0
Implemented on2017-1-1
Deliveryvia email in 1~3 business day
Detail of GB 18278.1-2015
Standard No.
GB 18278.1-2015
English Name
Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
Chinese Name
医疗保健产品灭菌 湿热 第1部分:医疗器械灭菌过程的开发、确认和常规控制要求
Chinese Classification
C47
Professional Classification
GB
ICS Classification
Issued by
AQSIQ; SAC
Issued on
2015-12-10
Implemented on
2017-1-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
GB 18278-2000 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
GB/T 20376-2006 Modified starch - Determination ofhydroxypropyl content - Method using proton nuclear magnetic resonance (NMR) spectrometry
GB/T 20367-2006 Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities
Language
English
File Format
PDF
Word Count
18500 words
Price(USD)
140.0
Keywords
GB 18278.1-2015, GB/T 18278.1-2015, GBT 18278.1-2015, GB18278.1-2015, GB 18278.1, GB18278.1, GB/T18278.1-2015, GB/T 18278.1, GB/T18278.1, GBT18278.1-2015, GBT 18278.1, GBT18278.1
Introduction of GB 18278.1-2015
Contents of GB 18278.1-2015
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Keywords:
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