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    CE Marking Specialists


    A South Wales based Product  Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations


  • Specialists in EMC and Low Voltage

    (Safety) Directives


    We specialise in European and Worldwide approvals.

  • Flexible, Professional, and Affordable Service


    We are a small organisation employing only

    highly experienced associates.

Category: News

New List of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) published in the Official Journal

Updated on date by author

A new list of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) was published in the Official Journal on May 13, 2016 – OJ C173

9 new standards have been added:

  • EN 556-2:2015 (new) Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices
  • EN 1865-1:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment
  • EN 1865-2:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher
  • EN ISO 3826-4:2015 (new) Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
  • EN ISO 11137-1:2015 (new) 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, including Amd 1:2013)
  • EN ISO 11137-2:2015 (new) Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
  • EN ISO 13408-1:2015 (new) Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
  • EN ISO 13408-7:2015 (new) Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
  • EN 60601-1-2:2015 (new) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral
    Standard: Electromagnetic disturbances – Requirements and tests
Posted in Medical Devices Directive, New Standards/Directives, News |

Guidelines for the application of ISO 9001:2015 published

Updated on date by author

PD ISO/TS 9002:2016 Quality management systems — Guidelines for the application of ISO 9001:2015 has recently been published

This document has been developed to assist users to apply the quality management system requirements of ISO 9001:2015, and provides guidance, with a clause by clause correlation to Clauses 4 to 10 of ISO 9001:2015, (although it does not provide guidance on Annexes A and B). It gives examples of what an organization can do, but it does not add new requirements to ISO 9001.

The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization, and include descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization.

While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes.

Posted in New Standards/Directives, News, Quality management systems |

New List of Harmonised Standards for the Machinery Directive published in the Official Journal

Updated on date by author

A new list of Harmonised Standards for the Machinery Directive, (2006/42/EC + 95/16/EC) was published in the Official Journal on May 13, 2016 – OJ C 173

25 new standards have been added:

  • EN ISO 13849-1:2015 (new) Safety of machinery – Safety-related parts of control systems – Part 1: General principles for design (ISO 13849-1:2015)
  • EN ISO 13850:2015 (new) Safety of machinery – Emergency stop function – Principles for design (ISO 13850:2015)
  • EN ISO 14120:2015 (new) Safety of machinery – Guards – General requirements for the design and construction of fixed and movable guards (ISO 14120:2015)
  • EN ISO 14123-1:2015 (new) Safety of machinery – Reduction of risks to health resulting from hazardous substances emitted by machinery – Part 1: Principles and specifications for machinery manufacturers (ISO 14123-1:2015)
  • EN ISO 14123-2:2015 (new) Safety of machinery – Reduction of risks to health resulting from hazardous substances emitted by machinery – Part 2: Methodology leading to verification procedures (ISO 14123-2:2015)
  • EN 1570-1:2011+A1:2014 (new) Safety requirements for lifting tables – Part 1: Lifting tables serving up to two fixed landings
  • EN 1808:2015 (new) Safety requirements for suspended access equipment – Design calculations, stability criteria, construction – Examinations and tests
  • EN 1870-17:2012+A1:2015 (new) Safety of woodworking machines – Circular sawing machines – Part 17: Manual horizontal cutting cross-cut sawing machines with one saw unit (radial arm saws)
  • EN ISO 3266:2010/A1:2015 (new) Forged steel eyebolts grade 4 for general lifting purposes (ISO 3266:2010)
  • EN ISO 3691-6:2015 (new) Industrial trucks – Safety requirements and verification – Part 6: Burden and personnel carriers (ISO 3691-6:2013)
  • EN ISO 4254-1:2015 (new) Agricultural machinery – Safety – Part 1: General requirements (ISO 4254-1:2013)
  • EN 12779:2015 (new) Safety of woodworking machines – Chip and dust extraction systems with fixed installation – Safety requirements
  • EN 13020:2015 (new) Road surface treatment machines – Safety requirements
  • EN 14973:2015 (new) Conveyor belts for use in underground installations – Electrical and flammability safety requirements
  • EN 15503:2009+A2:2015 (new) Garden equipment – Garden blowers, vacuums and blower/vacuums – Safety
  • EN ISO 16089:2015 (new) Machine tools – Safety – Stationary grinding machines (ISO 16089:2015)
  • EN ISO 28927-8:2009/A1:2015 (new) Hand-held portable power tools – Test methods for evaluation of vibration emission – Part 8: Saws, polishing and filing machines with reciprocating action and saws with oscillating or rotating action (ISO 28927-8:2009)
  • EN 60335-2-8:2015 (new) Household and similar electrical appliances – Safety – Part 2-8: Particular requirements for shavers, hair clippers and similar appliances
  • EN 60745-2-3:2011/A13:2015 (new) Hand-held motor-operated electric tools – Safety – Part 2-3: Particular requirements for grinders, polishers and disk-type sanders
  • EN 62841-2-2:2014/AC:2015 (new) Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-2: Particular requirements for hand-held screwdrivers and impact wrenches (IEC 62841-2-2:2014, modified)
  • EN 62841-2-4:2014/AC:2015 (new) Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-4: Particular requirements for hand-held sanders and polishers other than disc type (IEC 62841-2-4:2014, modified)
  • EN 62841-2-14:2015 (new) Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-14: Particular requirements for hand-held planers
  • EN 62841-3-1:2014/AC:2015 (new) Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 3-1: Particular requirements for transportable table saws (IEC 62841-3-1:2014, modified)
  • EN 62841-3-9:2015 (new) Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 3-9: Particular requirements for transportable mitre saws
  • EN 62841-3-10:2015 (new) Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 3-10: Particular requirements for transportable cut-off machines
Posted in Machinery Directive, News |

Gainspeed Christmas Newsletter

Updated on date by author

This months Gainspeed newsletter is here. Its a friendly complimentary newsletter on everything compliance.

Some of this months features are.

Headlines
Standards Watch

European standards being withdrawn
EU Directives changing
Lists of European Harmonised Standards

Update on Harmonised Standards Lists –
Update on UK Legislation
New Standards

National and international standards of interest published in recent months
PD ISO/TS 9002:2016
ETSI EN 300 328 V2.1.1

Compliance Calendar

From the Gainspeed team we wish you all a happy Christmas and wonderful new year!

Posted in News, News Letter |

June Gainspeed newsletter packed with latest Compliance news!

Updated on date by author

The new June Gainspeed newsletter is here. Its a friendly complimentary newsletter on everything compliance.

Some of this months features are.

Headlines

  • Standards Watch
    • European standards being withdrawn
    • EU Directives changing
    • Lists of European Harmonised Standards
  • The RoHS Guide 2016
    • NMRO – Guidance to RoHS Directive 2011/65/EU
  • Guidance from the EU
    • EMC Directive (2014/30/EU)
  • Update on Harmonised Standards Lists –
  • Compliance Calendar
Posted in News, News Letter |