Standardization
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Lang
Status
Published
Pages
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English
Withdrawn 
2004-01-22  
24 
49.20 BGN 
The standard is available on PDF file.
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Information supplied by the manufacturer with medical devices
English
Withdrawn 
2009-08-21  
27 
54.40 BGN 
The standard is available on PDF file.
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Information supplied by the manufacturer of medical devices
English
Withdrawn 
2003-11-20  
16 
31.10 BGN 
The standard is available on PDF file.
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Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
English
Withdrawn 
2003-11-20  
32 
59.60 BGN 
The standard is available on PDF file.
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Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance
English
Withdrawn 
2003-11-20  
17 
35.00 BGN 
The standard is available on PDF file.
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Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques
English
Withdrawn 
2006-08-10  
63 
123.10 BGN 
The standard is available on PDF file.
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Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
English
Withdrawn 
2003-10-23  
15 
31.10 BGN 
The standard is available on PDF file.
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)
English
Withdrawn 
2003-10-23  
21 
42.80 BGN 
The standard is available on PDF file.
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)
English
Withdrawn 
2004-03-19  
83 
149.00 BGN 
The standard is available on PDF file.
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Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
English
Published 
2006-12-27  
97 
149.00 BGN 
The standard is available on PDF file.
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Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
English
Published 
2008-09-05  
106 
178.80 BGN 
The standard is available on PDF file.
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Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
English
Published 
2010-05-21  
47 
90.70 BGN 
The standard is available on PDF file.
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Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Bulgarian
Withdrawn 
1999  
16 
31.10 BGN 
The standard is available on PDF file.
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Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
Bulgarian
Withdrawn 
1999  
14 
27.20 BGN 
The standard is available on PDF file.
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Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
English
Withdrawn 
2004-03-19  
31 
59.60 BGN 
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Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
Bulgarian
Withdrawn 
2001-06-04  
18 
35.00 BGN 
The standard is available on PDF file.
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Clinical investigation of medical devices for human subjects
Bulgarian
Withdrawn 
2000-06-19  
42 
81.60 BGN 
The standard is available on PDF file.
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Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
Bulgarian
Withdrawn 
2000-06-19  
38 
72.60 BGN 
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Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Bulgarian
Withdrawn 
2000-06-19  
26 
49.20 BGN 
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Sterilization of medical devices - Validation and routine control of sterilization by moist heat
Bulgarian
Withdrawn 
2000-06-19  
19.40 BGN 
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Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
English
Published 
2004-01-22  
10 
19.40 BGN 
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Bulgarian
Published 
2020-03-16  
10 
19.40 BGN 
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
English
Withdrawn 
2004-07-30  
11 
23.30 BGN 
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Bulgarian
Published 
2020-03-16  
17 
35.00 BGN 
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Sterilization of medical devices - Requirements for medical devices to be designated ''''STERILE" - Part 2: Requirements for aseptically processed medical devices
English
Published 
2015-12-15  
18 
35.00 BGN 
The standard is available on PDF file.
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Sterilization of medical devices - Requirements for medical devices to be designated ''''STERILE" - Part 2: Requirements for aseptically processed medical devices
Bulgarian
Withdrawn 
2003-05-10  
0.00 BGN 
The standard is available on PDF file.
Medical electrical equipment - Part 1: General requirements for safety
Bulgarian
Withdrawn 
2003-05-10  
0.00 BGN 
The standard is available on PDF file.
Medical electrical equipment - Part 1: General requirements for safety
Bulgarian
Withdrawn 
2003-05-10  
0.00 BGN 
The standard is available on PDF file.
Medical electrical equipment - Part 1: General requirements for safety
Bulgarian
Withdrawn 
2003-05-10  
198 
272.20 BGN 
The standard is available on PDF file.
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Medical electrical equipment - Part 1: General requirements for safety
English
Published 
2006-12-27  
399 
466.60 BGN 
The standard is available on PDF file.
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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