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Norm
ÖNORM EN 1639
Issue date: 2004 08 01
Dentistry - Medical devices for dentistry - Instruments
This European Standard specifies general requirements for instruments used in the practice of dentistry and which
are medical devices. It includes requirements for inten...
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Withdrawn
: 2010 03 15
Publisher:
Austrian Standards International
Format:
Digital | 15 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This European Standard specifies general requirements for instruments used in the practice of dentistry and which
are medical devices. It includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by the level 2 and level 3 standards, for dental equipment. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.
Norm
ÖNORM EN ISO 8325
Issue date :
2004 12 01
Dentistry - Test methods for rotary instruments (ISO 8325:2004)
Norm
ÖNORM EN ISO 6360-2
Issue date :
2005 02 01
Dentistry - Number coding system for rotary instruments - Part 2: Shapes (ISO 6360-2:2004)
Norm
ÖNORM ISO 8601
Issue date :
2006 07 01
Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601:2004)
Norm
ÖNORM EN 21942-3
Issue date :
1994 05 01
Dental vocabulary - Part 3: Dental instruments (ISO 1942-3:1989)
Norm
ÖNORM EN ISO 9168
Issue date :
2009 11 01
Dentistry - Hose connectors for air driven dental handpieces (ISO 9168:2009)
Norm
ÖNORM EN ISO 11135-1
Issue date :
2007 08 01
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Norm
ÖNORM EN ISO 11137-3
Issue date :
2006 07 01
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
Norm
ÖNORM EN ISO 11137-1
Issue date :
2006 07 01
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
Norm
ÖNORM EN ISO 17665-1
Issue date :
2006 11 01
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
Norm
ÖNORM EN ISO 3630-1
Issue date :
2008 05 01
Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
Norm
ÖNORM EN ISO 1797-1
Issue date :
1995 09 01
Dental rotary instruments - Shanks - Part 1: Shanks made of metals (ISO 1797-1:1992)
Norm
ÖNORM EN ISO 2157
Issue date :
1996 01 01
Dental rotary instruments - Nominal diameters and designation code number (ISO 2157:1992)
Norm
ÖNORM EN ISO 1797-2
Issue date :
1995 09 01
Dental rotary instruments - Shanks - Part 2: Shanks made of plastics (ISO 1797-2:1992)
Norm
ÖNORM EN ISO 7711-2
Issue date :
1996 05 01
Dental rotary instruments - Diamond instruments - Part 2: Discs (ISO 7711-2:1992)
Norm
ÖNORM EN ISO 10323
Issue date :
1996 05 01
Dental rotary instruments - Bore diameters for discs and wheels (ISO 10323:1991)
Norm
ÖNORM EN ISO 7711-3
Issue date :
2005 02 01
Dentistry - Diamond rotary instruments - Part 3: Grit sizes, designation and colour code (ISO 7711-3:2004)
Norm
ÖNORM EN ISO 9173-1
Issue date :
2006 08 01
Dentistry - Extraction forceps - Part 1: General requirements and test methods (ISO 9173-1:2006)
Norm
ÖNORM EN ISO 13397-1
Issue date :
1996 07 01
Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)
Norm
ÖNORM EN ISO 13295
Issue date :
2007 10 01
Dentistry - Mandrels for rotary instruments (ISO 13295:2007)
Norm
ÖNORM EN ISO 3630-3
Issue date :
1996 10 01
Dental root-canal instruments - Part 3: Condensers, pluggers and spreaders (ISO 3630-3:1994)
Norm
ÖNORM EN ISO 13397-2
Issue date :
2005 10 01
Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type (ISO 13397-2:2005)
Norm
ÖNORM EN ISO 13397-3
Issue date :
1997 02 01
Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-Type (ISO 13397-3:1996)
Norm
ÖNORM EN ISO 7785-2
Issue date :
1998 05 01
Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
Norm
ÖNORM EN ISO 13397-4
Issue date :
1998 07 01
Periodontal curettes, dental scalers and excavators - Part 4: Dental excavators - Discoid-type (ISO 13397-4:1997)
Norm
ÖNORM EN 1041
Issue date :
2008 11 01
Information supplied by the manufacturer with medical devices
Norm
ÖNORM EN ISO 7711-1
Issue date :
2009 11 01
Dental rotary instruments - Diamond instruments - Part 1: Dimensions, requirements, marking and packaging (ISO 7711-1:1998, including Amd 1:2009)
Norm
ÖNORM EN ISO 3823-1
Issue date :
1999 05 01
Dental rotary instruments - Burs - Part 1: Steel and carbide burs (ISO 3823-1:1997)
Norm
ÖNORM EN ISO 7885
Issue date :
2001 06 01
Sterile dental injection needles for single use (ISO 7885:2000)
Norm
ÖNORM EN ISO 7785-1
Issue date :
1999 09 01
Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
Norm
ÖNORM EN ISO 15606
Issue date :
2000 05 01
Dental handpieces - Air-powered scalers and scaler tips (ISO 15606:1999)
Norm
ÖNORM EN ISO 15098-2
Issue date :
2000 07 01
Dental tweezers - Part 2: Meriam types (ISO 15098-2:2000)
Norm
ÖNORM EN ISO 15098-3
Issue date :
2000 07 01
Dental tweezers - Part 3: College types (ISO 15098-3:2000)
Norm
ÖNORM EN ISO 9873
Issue date :
2000 09 01
Dental hand instrument - Reusable mirrors and handles (ISO 9873:1998)
Norm
ÖNORM EN ISO 15087-2
Issue date :
2001 01 01
Dental elevators - Part 2: Warwick James elevators (ISO 15087-2:2000)
Norm
ÖNORM EN ISO 15087-6
Issue date :
2001 01 01
Dental elevators - Part 6: Flohr elevators (ISO 15087-6:2000)
Norm
ÖNORM EN ISO 15087-5
Issue date :
2001 01 01
Dental elevators - Part 5: Bein elevators (ISO 15087-5:2000)
Norm
ÖNORM EN ISO 15087-4
Issue date :
2001 01 01
Dental elevators - Part 4: Coupland elevators (ISO 15087-4:2000)
Norm
ÖNORM EN ISO 15087-3
Issue date :
2001 01 01
Dental elevators - Part 3: Cryer elevators (ISO 15087-3:2000)
Norm
ÖNORM EN ISO 7153-1
Issue date :
2001 02 01
Surgical instruments - Metallic Materials - Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999)
Norm
ÖNORM EN ISO 13402
Issue date :
2001 02 01
Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:1995)
Norm
ÖNORM EN ISO 3630-2
Issue date :
2001 06 01
Dental root-canal instruments - Part 2: Enlargers (ISO 3630-2:2000)
Norm
ÖNORM EN ISO 15098-1
Issue date :
2001 06 01
Dental tweezers - Part 1: General requirements (ISO 15098-1:2000)
Norm
ÖNORM EN ISO 15087-1
Issue date :
2002 02 01
Dental elevators - Part 1: General requirements (ISO 15087-1:1999)
Norm
ÖNORM EN 556-1
Issue date :
2006 12 01
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
Norm
ÖNORM EN ISO 3823-2
Issue date :
2008 11 01
Dentistry - Rotary bur instruments - Part 2: Finishing burs (ISO 3823-2:2003 + Amd. 1:2008) (consolidated version)
Norm
ÖNORM EN ISO 21533
Issue date :
2003 12 01
Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)
Norm
ÖNORM EN ISO 6360-1
Issue date :
2004 08 01
Dentistry - Number coding system for rotary instruments - Part 1: General characteristics (ISO 6360-1:2004)