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A list of some of the most important standards and guidelines issued in 2011

This is not a comprehensive list of global medical device standards and guidelines. Instead, SGS aims to list documents of wide interest published since the end of 2010. Guidelines listed are those published in English that are of general interest to a wide range of manufacturers.

Considerations before purchase of a new standard

Before manufacturers consider purchasing a new standard, they should assure themselves that it is the most appropriate version of publication (e.g. ISO or national version) and that where a standard has been reissued the changes are technically significant.

Future updates

Future SGS Standards and Guidelines Updates will list subsequently published documents but will not repeat those listed in this issue of the SGS Medical Devices Newsletter.

Current position on European harmonization

For those manufacturers CE marking medical devices, European harmonization is an important step in the adoption of standards. The current position can be checked via the following links but be aware that updates to these lists were made in January 2011 and May 2011.


SGS selected list of standards and guidelines issued in 2011


EN Standards:

  • Published March 2011
    • EN 13795:2011 – Surgical Drapes, Gowns and Clean Air Suits, Used as Medical Devices for Patients, Clinical Staff and Equipment: General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
    • EN 15986:2011 – Symbol for Use in the Labeling of Medical Devices: Requirements for labeling of medical devices containing phthalates
    • Published April 2011
      • EN 60601-2-52:2010/AC:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of medical beds (Part 2-52)
      • EN 80001-1:2011 – Application of Risk Management: IT-networks incorporating medical devices
      • Published May 2011
        • EN 13976-1:2011 – Rescue Systems: Transportation of incubators - interface conditions (Part 1)
        • EN 13976-2:2011 – Rescue Systems: Transportation of incubators - system requirements (Part 2
        • EN 50527-2-1:2011 – Procedure for the Assessment of the Exposure to Electromagnetic Fields of Workers Bearing Active Implantable Medical Devices: Specific assessment for workers with cardiac pacemakers (Part 2-1)

        IEC Standards:

        • Published January 2011
          • IEC 60601-2-57:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (Part 2-57)
          • Published February 2011
            • IEC 60601-2-23:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (Part 2-23)
            • IEC 60601-2-45:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices (Part 2-45)
            • IEC 60601-2-49:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (Part 2-49)
            • IEC 60731:2011 – Medical Electrical Equipment: Dosimeters with ionization chambers as used in radiotherapy
            • Published March 2011
              • IEC 60601-2-27:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (Part 2-27)
              • Published May 2011
                • IEC 60601-2-34:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (Part 2-34)
                • Published June 2011
                  • IEC 60601-2-31:2008+A1:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source (Part 2-31)

                  ISO Standards

                  • Published December 2010
                    • ISO 20857:2010 – Sterilization of Health Care Products: Dry heat - requirements for the development, validation and routine control of a sterilization process for medical devices
                    • Published February 2011
                      • ISO 23409:2011 - Male Condoms: Requirements and test methods for condoms made from synthetic materials
                      • Published March 2011
                        • ISO 11040-2:2011 – Prefilled Syringes: Plunger stoppers for dental local anesthetic cartridges (Part 2)
                        • ISO 13926-2:2011 – Pen Systems: Plunger stoppers for pen-injectors for medical use (Part 2)
                        • ISO 14534:2011 – Ophthalmic Optics: Contact lenses and contact lens care products - fundamental requirements
                        • ISO 80601-2-61:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of pulse oximeter equipment (Part 2-61)
                        • Published April 2011
                          • ISO 14155:2011 – Clinical Investigation of Medical Devices for Human Subjects: Good clinical practice
                          • ISO 15883-6:2011 – Washer-Disinfectors: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (Part 6)
                          • ISO 80601-2-12:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of critical care ventilators (Part 2-12)
                          • Published May 2011
                            • ISO 11979-8:2009/A1:2011 – Ophthalmic Implants: Intraocular lenses fundamental requirements (Part 8 - Amendment 1)
                            • ISO 13212:2011 – Ophthalmic Optics: Contact lens care products - guidelines for determination of shelf-life
                            • ISO 16974:2011 – Respiratory Protective Devices: Marking and information supplied by the manufacturer
                            • ISO 19218-1:2011 – Medical Devices: Hierarchical coding structure for adverse events - event-type codes (Part 1)
                            • ISO 23908:2011 – Sharps Injury Protection: Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling - requirements and test methods
                            • Published June 2011
                              • ISO 7439:2011 – Copper-Bearing Contraceptive Intrauterine Devices: Requirements and tests
                              • ISO 11073-10407:2011 – Health Informatics: Personal health device communication; Device specialization - blood pressure monitor
                              • ISO 13408-1:2011 – Aseptic Processing of Health Care Products: General requirements (Part 1)
                              • ISO 13408-2:2011 – Aseptic Processing of Health Care Products: Filtration (Part 2)
                              • ISO 13408-3:2011 – Aseptic Processing of Health Care Products: Lyophilization (Part 3)
                              • ISO 13408-4:2011 – Aseptic Processing of Health Care Products: Clean-in-place technologies (Part 4)
                              • ISO 13408-5:2011 – Aseptic Processing of Health Care Products: Sterilization-in-place (Part 5)
                              • ISO 13408-6:2011 – Aseptic Processing of Health Care Products: Isolator systems (Part 6)
                              • ISO 18308:2011 – Health Informatics: Requirements for an electronic health record architecture
                              • ISO 22413:2011 – Transfer Sets for Pharmaceutical Preparations: Requirements and test methods
                              • ISO 25424:2011 – Sterilization of Medical Devices: Low temperature steam and formaldehyde - requirements for development, validation and routine control of a sterilization process for medical devices
                              • Published July 2011
                                • ISO 7711-2:2011 – Dentistry: Rotary diamond instruments - Discs (Part 2)
                                • ISO 11990-1:2011 – Lasers and Laser-Related Equipment: Determination of laser resistance of tracheal tubes - tracheal tube shaft (Part 1)
                                • ISO 14160:2011 – Sterilization of Health Care Products: Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices
                                • ISO 25841:2011 – Female Condoms: Requirements and test methods

                                EC Commission Guidance:

                                • Published June 2010
                                  • MEDDEV 2.4/1 Rev. 9 – Classification of Medical Devices: Guidelines relating to application directive 93/42/EEC medical devices
                                  • Published December 2010
                                    • MEDDEV 2.7/3 – Clinical Investigations: Serious adverse event reporting under directives 90/385/EEC AND 93/42/EEC
                                    • MEDDEV 2.7/4 – Guidelines on Clinical investigation: A guide for manufacturers and notified bodies
                                    • Published March 2011
                                      • Version 1.9 – Manual: Borderline and classification in the community regulatory framework for medical devices


                                      FDA Guidance:

                                      • Published February 7, 2011
                                        • 1734 – Class II Special Controls Guidance Document: Contact cooling system for aesthetic use
                                        • Published March 8, 2011
                                          • 1636 – Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence
                                          • Published March 23, 2011
                                            • 1707 – Class II Special Controls Guidance Document: Ovarian adnexal mass assessment score test system
                                            • Published April 13, 2011
                                              • 1687 – 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes
                                              • Published April 14, 2011
                                                • 1735 – Class II Special Controls Guidance Document: Low level laser system for aesthetic use
                                                • Published April 25, 2011
                                                  • 1582 – Class II Special Controls Guidance Document: Topical oxygen chamber for extremities
                                                  • Published May 17, 2011
                                                    • 1751 – Assembler's Guide to Diagnostic X-Ray Equipment
                                                    • Published July 15, 2011
                                                      • 1638 – Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
                                                      • Published July 20, 2011
                                                        • 1701 – Class II Special Controls Guidance Document: Focused ultrasound stimulator system for aesthetic use
                                                        • Published July 21, 2011
                                                          • 1597 – Class II Special Controls Guidance Document: Electrocardiograph electrodes
                                                          • Published July 26, 2011
                                                            • 1728 – Class II Special Controls Guidance Document: Repetitive transcranial magnetic stimulation (rTMS) systems


                                                            GHTF Guidance:

                                                            • Published September, 2010
                                                              • SG4/84:2010 – Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers: Audits of manufacturer control of suppliers (Part 5)
                                                              • SG4/83:2010 – Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers: Multiple site auditing (Part 4)
                                                              • SG4/N30:2010 – Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers: Regulatory auditing strategy (Part 2)


                                                              Health Canada Guidance:

                                                              •  Published January, 2010
                                                                • GUI-0059 – Guidance Document for Mandatory Problem Reporting for Medical Devices
                                                                •  Published March, 2011
                                                                  • GUI-0054 – Guide to Recall of Medical Devices
                                                                  • GUI-0065 – Guidance on Investigation of Reported Medical Device Problems
                                                                  • Published April, 2011
                                                                    • GUI-0016 – Guidance on Medical Device Establishment Licensing and Medical Device Establishment License Fees
                                                                    • Revised April, 2011 (Adopted June, 2005)
                                                                      • How to Complete the Application for a New Medical Device License/Medical Device License Amendment for a Private Label Medical Device
                                                                      • Revised April, 2011 (Adopted January, 1999)
                                                                        • How to Complete the Application for a New Medical Device License

                                                                      Hong Kong MDCO Guidance:

                                                                      • Published July, 2011
                                                                        • GN-02 – Guidance Notes for Listing Class II/III/IV Medical Devices
                                                                        • GN-06 – Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices

                                                                      TGA

                                                                      • Published May, 2011
                                                                        • Australian Regulatory Guidelines for Medical Devices (ARGMD)

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                                                                      Medical Device Team
                                                                      Website: www.sgs.com/medicaldevices

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