BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

BS EN ISO 15197:2015

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Status : Current   Published : June 2015

Format
PDF

Format
HARDCOPY



What is this standard about?

BS EN ISO 15197:2015 specifies requirements for in vitro glucose monitoring systems that measure capillary blood samples to help control diabetes. It also specifies guidelines for design verification procedures and for the validation of performance by intended users. 

Who is this standard for? 

  • Manufacturers of in vitro glucose monitoring systems
  • Users of in vitro glucose monitoring systems
  • Regulatory and conformity authorities with responsibility for assessing the performance of these systems

Why should you use this standard? 

Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. This is caused by a relative or absolute deficiency in insulin secretion or by insulin resistance leading to abnormal concentrations of glucose in the blood, which may result in acute and chronic health complications. When used properly, a glucose monitoring system allows the user to monitor and take action to control the concentration of glucose present in the blood.

BS EN ISO 15197 is intended for blood-glucose monitoring systems used by lay persons. It outlines requirements for acceptable performance and specifies procedures for demonstrating conformance to this international standard.

What’s changed since the last update?

BS EN ISO 15197 has been systematically reviewed by experts, who have taken into consideration medical developments and changes to clinical best practice. Changes include:

  • Revised performance criteria
  • New considerations concerning the basis for the minimum analytical performance of blood glucose devices intended for self-monitoring, described in Annex C
  • Amendments to safety and reliability testing criteria and user performance evaluation



Standard NumberBS EN ISO 15197:2015
TitleIn vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
StatusCurrent
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)ISO 13485, ISO 14971, ISO 17511, ISO 18113-1, ISO 18113-4, ISO 18113-5, ISO 23640, IEC 60068-2-64, IEC 61010-1, IEC 61010-2-101, IEC 61326-1, IEC 61326-2-6, IEC 62366, EN 13612, EN ISO 13485:2012, EN ISO 14971:2012, EN ISO 17511:2003, EN ISO 18113-1:2011, EN ISO 18113-4:2011, EN ISO 18113-5:2011, EN ISO 23640:2014, EN 60068-2-64:2008, EN 61010-1:2010, EN 61010-2-101:2002, EN 61326-1:2013, EN 61326-2-6:2013, EN 62366:2008, EN 13612:2002
Informative References(Provided for Information)98/79/EC, ISO/IEC Guide 99:2007, ISO 5725-1, ISO 5725-2, ISO 5725-3
ReplacesBS EN ISO 15197:2013
International RelationshipsEN ISO 15197:2015,ISO 15197:2013
DescriptorsClinical investigation instruments, Glucose, Blood, Measurement
ICS11.040.55
11.100.10
Title in FrenchSystèmes d'essais de diagnostic in vitro. Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré
Title in GermanTestsysteme für die In-vitro-Diagnostik. Anforderungen an Blutzuckermesssysteme zur Eigenanwendung bei Diabetes mellitus
CommitteeCH/212
ISBN978 0 580 90800 2
PublisherBSI
FormatA4
DeliveryYes
Pages60
File Size2.083 MB
Price£254.00


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