Legal
Terms & Conditions
General
- U.S. regulations, 21 CFR Part 820 for a Class II medical device
- Directive 93/42/CEE annex II
- UNI CEI EN ISO 13485:2012 :“ Medical devices -- Quality management systems -- Requirements for regulatory purposes”
- UNI CEI EN ISO 14971 :2012 : Medical devices -- Application of risk management to medical devices
- CEI EN 62304:2006: Medical device software - Software life-cycle processes
- UNI EN ISO 9004:2009 Managing for the sustained success of an organization -- A quality management approach.
- UNI EN ISO 9000:2005 Quality management systems -- Fundamentals and vocabulary
- CEI EN 62353:2008: Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
- CEI UNI EN ISO 15223-1:2012 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
- IEC 62366:2007 “Medical devices – Application of usability engineering to medical devices”
Safety
- IEC 60601-1:2005: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2010: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-11 :2010 : Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EMC
- IEC 60601-1-2:2014 (fourth edition): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
- ETSI EN 301 489-17 V2.2.1 (2012-09)
- ETSI EN 300 328 V1.9.1 (2015-02)
- FCC Rules: Code of Federal Regulations (CFR) no. 47, Part 15 Subpart C Section 15.247
Biocompatibility
- ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- ISO 10993-5:2009 - “Cytotoxicity elution test”
- ISO 10993-10:2010 – Hyper sensitivity test
- ISO 10993-10:2010 – Skin irritation
Excluded standards
- 2006/42/CE
