Quality First International

Understanding the black sheep of standards: An analysis of EN ISO 14630 on non-active surgical implants and practicalities of its application

An eBook on the standard EN ISO 14630 written by Haroon Atchia analyses the controversial standard on non-active surgical implants whose latest version from 2012 is considered non compliant with the relevant legal requirements (Article 10. 6 of Regulation (EU) No 1025/2012) by the European Commission.

London, 4 December 2017

Haroon Atchia - CEO of the London-based medical device regulatory consultancy Quality First International - has written a profound analysis on the controversial standard EN ISO 14630 on non-active surgical implants whose latest version from 2012 is considered non compliant with the relevant legal requirements (Article 10. 6 of Regulation (EU) No 1025/2012) by the European Commission.

“It is hoped our research will assist manufacturers in understanding EN ISO 14630 more fully, including areas causing problems to the industry and offer recommendations on how conformity assessment can be managed. Additionally, results of our research could aid developers of the standard and support assessment of its adequacy by legislation”, says Haroon Atchia.


The Table of Contents:

Chapter 1 Standards and standardisation
Standards and standardisation in context of medical devices
ISO guides
  ISO Guide 2
  ISO Guide 63
Expertise required to produce standards
Chapter 2 Coherence between standards on non-active surgical implants
Position of ISO 16142 in ISO technical hierarchy
Position of ISO 14283 in ISO technical hierarchy
Fundamental principles of ISO/TR 14283
Headline changes ISO/TR 14283
Chapter 3 Scope of ISO 14630
Validity of State-of-the-Art
Applying requirements
Reasons to select EN ISO 14630
Critical examination of ISO/TR 16142
Critical examination of ISO/TR 14283
  §3 General principles
  §4 Specific principles regarding design and construction
Critical examination of EN ISO 14630:2012
  Design attributes
  Materials
  Design evaluation
  Manufacture
Chapter 4 Evaluation of information symmetry in non-active surgical implant standards, relation by property space and homology deduced from essential properties and substitution
Substitution of ISO/TR 14283 by ISO 11979-8
Design attributes from ISO 11979-8
Status of ISO 14630 for purposes of CE Marking
Method of illustrating correspondence between ISO 14630 elements and Essential requirements specified by Council Directive 93/42/EEC
Changes introduced by EN ISO 14630:2012
Consequences of non-Harmonisation status
Evaluation of differences between EN ISO 14630: 2012 and 2009 editions
Design attributes
Chapter 5 History, evolution and detailed examination of ISO 14630
History of ISO 14630
Extent and effect of leakage
Pre-clinical evaluation
Product life cycle
Requirements on materials
Candidate material suitable for intended purpose
Proven material
  Evaluation by direct comparison
  Application of test standard
  Demonstration of intended performance achieved by implant
Clinical evaluation
Performance management elements deduced from ISO 14630
Chapter 6 Adequacy and fitness for purpose of EN ISO 14630
Empirical studies on relation between quality management practices and innovation
Internal factors affecting change catalysis
Objective performance variables and ISO 14630 standard variable
 

The eBook may be requested from QFI by email to marija@qualityfirstint.com.

Price: $599 (plus VAT as applicable), 406 pages including covers, provided in PDF format.

About Quality First International (QFI)

QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.