Class II Medical Devices Class 19

Class II Medical Devices Class 19, Total:65 items.

The international standard classification for "Class II Medical Devices Class 19" includes: Surgical instruments and materials .

The Chinese standard classification for "Class II Medical Devices Class 19" includes: Medical apparatus and devices in general .

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Shanghai Provincial Standard of the People's Republic of China

• DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Guangdong Provincial Standard of the People's Republic of China

• DB4420/T 45-2024 Specifications for registration management of Class I medical device products

Professional Standard - Medicine

• YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature
• YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents
• YY 91055-1999 Paint coating for medical devices. Classification and speciation
• YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products

Group Standards of the People's Republic of China

• T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing

US Federal Contractor Registration (USFCR)

• FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES
• FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES

German Institute for Standardization

• DIN 58785:2010-02 Medical instruments - Ear specula type Hartmann
• DIN 58257:1983-02 Medical instruments; needle holder type Crile
• DIN 58257:2010-02 Medical instruments - Needle holder type Crile
• DIN 13452:2017-11 Medical instruments - Scissors type Kilner
• DIN 58858:2008-01 Medical Instruments - Director Type König
• DIN 13452:2006-12 Medical instruments - Scissors type Kilner
• DIN 58262:2010-02 Medical instruments - Mouth gag type Jennings
• DIN 58259:1976-03 Medical instruments; needle holder type Masson
• DIN 58259:2010-02 Medical instruments - Needle holder type Masson
• DIN 96111:2010-12 Medical instruments - Plaster knife type Körte
• DIN 96035:2009-12 Medical instruments - Haemostatic forceps type Semb
• DIN 58788:1982-09 Medical instruments; nasal specula type Hartmann-Halle
• DIN 58286:2010-02 Medical instruments - Retractor type Kocher
• DIN 58785:1982-09 Medical instruments; ear specula type Hartmann
• DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
• DIN 96086:2010-12 Medical instruments - Bone wire tightener type Loute
• DIN 96076:2010-12 Medical instruments - Self-retaining retractor type Wullstein
• DIN 96057:2009-12 Medical instruments - Raspatory type Sedillot
• DIN 58860:2010-02 Medical instruments - Osteotomes type Lexer
• DIN 58867:2010-02 Medical instruments - Septum knife type Brünings
• DIN 96101:2010-12 Medical instruments - Bone raspatory type Jansen
• DIN 58783:2010-02 Medical instruments - Ear curette type Buck
• DIN 96115 E:2010-05 Draft Document - Medical instruments - Gauges type Lexer
• DIN 96082:2010-12 Medical instruments - Self-retaining retractor type Beckmann-Adson
• DIN 58295:1983-02 Medical instruments; retractor type Volkmann
• DIN 58285:2008-01 Medical instruments - Retractor type Volkmann
• DIN 58858:2020-06 Draft Document - Medical instruments - Director type König
• DIN 13191:2005-12 Medical instruments - Rongeur type Stille
• DIN 96025:2009-12 Medical instruments - Ethmoid rongeur forceps type Craig
• DIN 13188:1983-02 Medical instruments; plaster cast spreader type Henning
• DIN 58259 E:2008-09 Draft Document - Medical instruments - Needle holder type Masson
• DIN 58240:2022-08 Draft Document - Medical instruments - Retractors type Israel
• DIN 58785 E:2008-09 Draft Document - Medical instruments - Ear specula type Hartmann
• DIN 58851:2010-02 Medical instruments - Cataract knives type Graefe
• DIN 58858 E:2020 Draft Document - Medical instruments - Director type König
• DIN 96091:2010-12 Medical instruments - Guiding probe type Brunner
• DIN 13198:2010-02 Medical instruments - Ethmoid rongeur forceps type Takahashi
• DIN 58286 E:2008-09 Draft Document - Medical instruments - Retractor type Kocher
• DIN 96036 E:2009-04 Draft Document - Medical instruments - Haemostatic forceps type Price-Thomas
• DIN 58860 E:2008-09 Draft Document - Medical instruments - Osteotomes type Lexer
• DIN-Fachbericht CEN TR 15133:2005-09 Terminology Medical device classification terms and codes
• DIN 13199:1982-10 Medical instruments; ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams
• DIN 96149:2011-12 Medical instruments - Bone curettes type Daubenspeck
• DIN 58295 E:2008-09 Draft Document - Medical instruments - Retractor type Volkmann
• DIN 96053 E:2009-04 Draft Document - Medical instruments - Retractor type Ollier
• DIN 96082 E:2010-05 Draft Document - Medical instruments - Self-retaining retractor type Beckmann-Adson
• DIN 96146 E:2011-04 Draft Document - Medical instruments - Retractors type Brunner
• DIN 13457:2010-02 Medical instruments - Urethral bougies and dilating sounds type Dittel

National Standardisation Body (ASRO)

• STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

European Union/Commission

• MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

Canadian Standards Association (CSA)

• CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
• CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)

Kingdom of Bahrain Testing and Metrology Directorate

• BH GSO 2628:2022 Medical devices and supplies classification criteria

GCC Standardization Organization

• GSO 2628:2021 Medical devices and supplies classification criteria

Ente Nazionale Italiano di Unificazione

• UNI ENV 12611:1997 Medical informatics. Categorial structure of systems of concepts. Medical devices.

Standard Association of Australia （SAA）

• AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements

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