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Class II Medical Device Inspection Standards

Class II Medical Device Inspection Standards, Total:23 items.

In the international standard classification, Class II Medical Device Inspection Standards involves: Medical equipment, Information sciences. Publishing, Sterilization and disinfection, Laboratory medicine.

Professional Standard - Medicine, Class II Medical Device Inspection Standards

• YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature

未注明发布机构, Class II Medical Device Inspection Standards

• YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents

American Society for Testing and Materials (ASTM), Class II Medical Device Inspection Standards

• ASTM F2401-16 Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
• ASTM E3263-20 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• ASTM E3263-22 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• ASTM E3263-22e1 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• ASTM F3438-21 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F2819-10(2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
• ASTM F2819-10(2015)e1 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
• ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F2382-17e1 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
• ASTM F2382-17 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
• ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
• ASTM E2314-03 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
• ASTM E2314-03(2014) Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

Canadian Standards Association (CSA), Class II Medical Device Inspection Standards

• CSA PLUS 14971-2007 The ISO 14971:2007 essentials — A practical handbook for implementing the ISO 14971 Standard for medical devices (Second Edition)

German Institute for Standardization, Class II Medical Device Inspection Standards

• DIN 96298-2:2016 Medical instruments - Terms, measuring methods and tests - Part 2: Measuring methods for the determination of basic measurements of surgical standard instruments
• DIN 96298-2:2016-10 Medical instruments - Terms, measuring methods and tests - Part 2: Measuring methods for the determination of basic measurements of surgical standard instruments

British Standards Institution (BSI), Class II Medical Device Inspection Standards

• BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
• BS EN 868-3:2009 Packaging for terminally sterilized medical devices - Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods

European Committee for Standardization (CEN), Class II Medical Device Inspection Standards

• EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

GOSTR, Class II Medical Device Inspection Standards

• GOST R 58484-2019 Non-active surgical implants. Implants based on hyaluronic acid. Standard guide to determining characteristics and conducting trials of hyaluronic acid, as an incipient basis for medical devices

Others:   Class II Medical Device Inspection Standards.