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Position: Chinese Standard in English/YY/T 0287-2017
YY/T 0287-2017   Medical devices-Quality management systems- Requirements for regulatory purposes (English Version)
Standard No.: YY/T 0287-2017 Status:valid remind me the status change
Language:English File Format:PDF
Word Count: 18500 words Price(USD):140.00 remind me the price change
Implemented on:2017-5-1 Delivery: immediately
Standard No.: YY/T 0287-2017
English Name: Medical devices-Quality management systems- Requirements for regulatory purposes
Chinese Name: 医疗器械 质量管理体系 用于法规的要求
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued by: China Food and Drug Administration
Issued on: 2017-01-19
Implemented on: 2017-5-1
Status: valid
Superseding:YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes
Language: English
File Format: PDF
Word Count: 18500 words
Price(USD): 140.00
Delivery: via email in 1 business day
Referred in YY/T 0287-2017:
*GB/T 19000-2016 Quality management systems―Fundamentals and vocabulary
*GB/T 9766.6-2021 Test method for tyre valve - Part 6: Test method for core
*GB/T 40904-2021 Methods for the determination of prohibited substances in furniture products and related materials—Azo dyes
*GB/T 40906-2021 Methods for the determination of prohibited substances in furniture products and related materials—Certain phthalate esters
*GB/T 40908-2021 Methods for the determination of prohibited substances in furniture products and related materials—Flame retardants
*GB/T 40971-2021 Methods for the determination of prohibited substance in furniture products and related materials—Polycyclic aromatic hydrocarbons
*GB/T 23799-2021 Methanol gasoline (M85) for motor vehicles
*GB/T 20096-2021 Roller skate
*GB/T 12678-2021 Reliability running test method for motor vehicles
*GB/T 12535-2021 Test method of starting performance for motor vehicle
*GB/T 5334-2021/XG1-2023 Passenger car―Wheels―Performance requirements and test methods for cornering and radial fatigue, includes Amendment 1
*GB/T 4985-2021 Standard test method for needle penetration of petroleum waxes
*GB/T 4942-2021 Degrees of protection provided by the integral design of rotating electrical machines (IP code)—Classification
*GB/T 3836.35-2021 Explosive atmospheres—Part 35:Classification of areas for explosive dust atmospheres
*GB/T 3836.31-2021 Explosive atmospheres—Part 31:Equipment dust ignition protection by enclosure “t”
*GB/T 3836.9-2021 Explosive atmospheres—Part 9:Equipment protection by encapsulation “m”
YY/T 0287-2017 is referred in:
*YY/T 1630-2018 Fundamental requirements for unique device identifier
*YY/T 1737-2020 Analytical method for bioburden control level of medical device
*GB 24627-2009 Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants
*YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
*YY/T 1553-2017 Cardiovascular implants-Cardiac occluder
*YY/T 0308-2015 Medical sodium hyaluronate gel
*04G101-4 Cast-in-place R.C. floor plate and roof sheathing, applicable to such major structures as concrete structure and masonry structure
*GB/T 42218-2022 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
*HG 20601-1997 Steel pipe blank flanges (Europe System)
*GB 23200.8-2016 National food safety standard―Determination of 500 pesticides and related chemicals residues in fruits and vegetables Gas chromatography-mass spectrometry
*NY 5045-2008 Pollution-free food fresh milk
*YY/T 0633-2008 Ophthalmic instruments―Indirect ophthalmoscopes
*YY/T 0676-2008/XG1-2021 Ophthalmic instruments-Perimeters
*GB/T 19214-2008 Electrical accessories―Residual current monitors (RCM) for household and similar uses
*GB/T 24359-2009 Quality requirements for third party logistics service
*GB/T 18391.6-2009 Information technology—Metadata registries (MDR)—Part 6:Registration
*GB/T 13917.1-2009 Laboratory efficacy test methods and criterions of public health insecticides for pesticide registration - Part 1: Spray fluid
*GB 1354-2009 Rice
*GB 19359-2009 Safety code for inspection of packaging of dangerous goods transported by railway
*GB 7465-2009 High activity cobalt-60 sealed radioactive sources
*GB/T 537-2009 Disodium tetraborate decahydrate for industrial use
*GB/T 14144-2009 Testing method for determination of radial interstitial oxygen variation in silicon
*GB/T 6624-2009 Standard method for measuring the surface quality of polished silicon slices by visual inspection
*GB/T 23821-2009 Safety of machinery—Safety distances to prevent hazard zones being reached by upper and lower limbs
*GB/T 23571-2009 Metal-cutting machine tool - Technic document compiled
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