Medical Newsletter
Welcome to the fourth edition of the 2008 ‘Medical Testing Times’ from TÜV Product Service. This newsletter is designed to keep you informed about changes within the industry – updates to requirements, new services we offer, events we are exhibiting at and other relevant news. For more information on any of the stories please email us at: info@tuvps.co.uk
2008 round-upHappy Christmas! 2008 has been a busy year – we have seen changes to a number of regulatory requirements from ISO 17021 (which governs the way that notified bodies conduct audits) to the revision of the Medical Devices Directive itself (which should be transposed into national laws by 21st December this year).
We successfully grew our Medical Audit Team with both Norman Richardson and Etienne Lombard joining us as experienced auditors. Norman, in particular, has brought valuable knowledge in non-active medical devices, which has already allowed us to assist more effectively manufacturers who require EMC and safety testing as part of their compliance requirements. As Norman and Etienne have been working towards full authorisation as Notified Body Lead Auditors, we have continued to be supported by other auditors from the European TÜV Product Service group to ensure that you continue to receive the same high standard of service and have access to the appropriate expertise for your medical devices. As our business continues to grow we will recruit additional auditors so that you can enjoy a greater level of local support from our UK team.
For those certified to ISO 9001, the 2008 version was published last month. Listed below are many of the medical device related standards that were published in 2008; please note that this is not an exhaustive list. In addition, many standards published prior to 2008 are in transition and will come into force in the next year (e.g. radiation and moist heat sterilization).
As another year draws to a close we wish you a Happy Christmas and relaxing break, ready to start afresh in 2009. We look forward to working with you over the coming year in continuing to help you to derive the maximum value from your management system and market compliant products in the international marketplace.
Changes to medical device related standards in 2008 include:
· BS EN 285:2006+A1:2008 Sterilization. Steam sterilizers. Large sterilizers
· BS EN 980:2008
Symbols for use in the labelling of medical devices· BS EN 1041:2008
Information supplied by the manufacturer of medical devices· BS EN ISO 3630-1:2008 Dentistry. Root-canal instruments. General requirements and test methods
· EN ISO 5359:2008
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)· BS EN ISO 6872:2008 Dentistry. Ceramic materials
· BS ISO 7176-5:2008 Wheelchairs. Determination of dimensions, mass and manoeuvring space
· BS EN ISO 8536-1:2008 Infusion equipment for medical use. Infusion glass bottles
· BS EN ISO 8537:2008 Sterile single-use syringes, with or without needle, for insulin
· BS EN ISO 8836:2008 Suction catheters for use in the respiratory tract
· BS EN ISO 9001:2008
Quality management systems. Requirements· BS EN ISO 9187-1:2008 Injection equipment for medical use. Ampoules for injectables
· EN ISO 10524-4:2008
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)· EN ISO 14630:2008
Non-active surgical implants - General requirements (ISO 14630:2008)· EN 15546-1:2008
Small bore connectors for liquids and gases in healthcare applications - Part 1 - General Requirements· BS EN ISO 15883-4:2008 Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
· BS EN ISO 20795-1:2008 Dentistry. Base polymers. Denture base polymers
· BS EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use. Salt test method to assess filtration performance
· BS EN ISO 23328-2:2008 Breathing system filters for anaesthetic and respiratory use. Non-filtration aspects
· BS EN 45502-2-2:2008 Active implantable medical devices. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
· BS EN 60601-1-3:2008 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment
· BS EN 60601-1-9:2008
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for environmentally conscious design· BS EN 60601-1-10:2008 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Requirements for the development of physiologic closed-loop controllers
· BS EN 60601-2-33:2002+A2:2008 Medical electrical equipment. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
· BS EN 60601-2-37:2008 Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
· EN 60601-2-39:2008 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)
· PD IEC/TR 60977:2008 Medical electrical equipment. Medical electron accelerators. Guidelines for functional performance characteristics
· BS EN 61217:1996+A2:2008, IEC 61217:1996 Radiotherapy equipment. Coordinates, movements and scales
· BS EN 62353:2008 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
· BS EN 62366:2008 Medical devices. Application of usability engineering to medical devices
Feedback about ISO 17021 implementation
In line with the ISO 17021 requirements governing Certification Bodies, the changes to approval of audit findings are now implemented. All Minor Non-Conformities (MNC) now require root causes as well as planned corrections and corrective actions to be submitted after the audit. These are reviewed and require approval by the audit team prior to closing the audit file and submitting it to the certification panel. For formal Non-Conformities (NC), the Corrections and Corrective actions have to be taken and evidence submitted in addition to the root cause analysis. The audit team will continue to review effectiveness at the next audit.
As part of this change, we will be wording MNCs and NCs more carefully so that there is a clear statement of the finding, reference to the requirement and examples to give the objective evidence to support the finding.
Next Newsletter
We will continue to forward this quarterly Medical Testing Times in 2009. Some future topics will include changes to the Medical Devices Directive; corrections, corrective action and preventive action; process risk management; the process approach; technical documentation, and many more!
Upcoming Events
• Informa, Brussels 27/28 January 2009 – Norman Richardson will be speaking alongside other leading figures from the medical devices industry at the Informa Conference on “Managing the Revisions to the Medical Device Directive”. Norman’s presentation will cover “Evaluating conformity assessment changes”. Further details can be found at the following Informa link:
http://www.iir-events.com/IIR-Conf/Page.aspx?nrid=9315&id=15219&vip=GDJRKCS
• MEDTECUK, Birmingham UK 25/26 March 2009 – Henry Sibun will be speaking at this major UK event. With the transposition of the revisions to the Medical Devices Directive due to be published by 2008-12-21 and be in force across the EU by 2010-03-21, manufacturers need to be already implementing these changes. Notified Bodies will start to look at compliance with the revisions in 2009 and enforce them in 2010.Henry will give an overview of some of the consequences and challenges for medical device manufacturers as a result of these changes. The full agenda for the conference will be published shortly at: http://www.devicelink.com/expo/mdt09/
Past Events
- Norman Richardson spoke about the Essential Performance requirements for active devices at the Electro-Medical Devices Conference arranged by Informa in Brussels on 2/3 December.
Useful Links
Standards Harmonised against the Medical Devices Directive:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html
Guidance documents from the European Commission:
http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm
Global Harmonisation Taskforce guidance documents:
TÜV Product Service Ltd medical device “MedInfo” guidance documents:
http://www.tuvps.co.uk/home_en/industries/medical_health/med-info_guidance_documents
