EN ISO 81060-2:2019/A1:2020

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden automatisierten Bauart - Änderung 1 (ISO 81060-2:2018/Amd 1:2020)

No scope available

Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à mesurage automatique - Amendement 1 (ISO 81060-2:2018/Amd 1:2020)

Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst merjenja s prekinitvami - Dopolnilo A1 (ISO 81060-2:2018/Amd 1:2020)

General Information

• Status: Published
• Publication Date: 15-Sep-2020
• Withdrawal Date: 30-Mar-2021
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Sep-2020
• Due Date: 17-Jul-2022
• Completion Date: 16-Sep-2020
• Ref Project: SIST EN ISO 81060-2:2020/A1:2020 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)

Relations

• Amends: EN ISO 81060-2:2019 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
• Effective Date: 04-Feb-2020

Overview

EN ISO 81060-2:2019/A1:2020 is an important amendment to the international standard governing non-invasive sphygmomanometers, specifically focusing on the clinical investigation of intermittent automated blood pressure measurement devices. Developed jointly by ISO Technical Committee ISO/TC 121 and CEN Technical Committee CEN/TC 205, this amendment updates Part 2 of the ISO 81060 standard series, ensuring improved accuracy and consistency in clinical evaluations. The document applies to automated intermittent sphygmomanometers used for blood pressure monitoring without invasive methods.

The amendment updates key elements regarding subject limb size distribution, cuff specifications, and clinical investigation reporting. It enforces rigorous testing protocols to better represent diverse patient populations and enhance device reliability.

Key Topics

• Limb Circumference Range Requirements

  • Defines total limb circumference range as the spectrum from smallest to largest limb circumference intended by the manufacturer.
  • Mandates at least 20% of test subjects to fall into each quarter of the total limb circumference range.
  • Requires minimum 10% of subjects to fall within both the highest and lowest octiles of the limb circumference range.
  • Specifies formulas to distribute testing subjects across multiple cuff sizes when applicable.

• Cuff Design and Reference Specifications

  • Reference cuffs must include a bladder length measuring 75% to 100% of the upper arm circumference.
  • Bladder width must be 37% to 50% of the upper arm circumference.
  • Cuffs shall have a two-piece construction: distensible inner bladder and non-distensible outer sleeve.
  • Ensures cuff design compatibility with varying limb sizes for accurate readings.

• Clinical Investigation Reporting

  • Reports must detail each cuff's specified arm circumference range in centimeters and inches.
  • Inclusion of plots correlating arm circumference to the difference between device and reference blood pressure readings.
  • Separate plots required for both systolic and diastolic blood pressure values.
  • Visual demarcation of cuff size borders on plots to facilitate scientific review.

• Compliance Verification

  • National bodies are tasked with adopting this amendment as a national standard.
  • Conflicting national standards must be withdrawn to harmonize sphygmomanometer clinical testing.
  • Focus on patent rights notification related to the document's technical content.

Applications

This standard amendment is critical for manufacturers, clinical researchers, and regulatory bodies involved in the development, testing, and certification of non-invasive automated sphygmomanometers. Practical applications include:

• Medical Device Development
  Ensures product design incorporates appropriate cuff sizes and limb distribution considerations to suit diverse patient populations.

• Clinical Trials and Validation
  Standardizes protocols for blood pressure monitoring device validation through rigorous clinical investigations ensuring measurement accuracy.

• Regulatory Compliance
  Assists regulatory authorities in Europe and internationally in assessing device conformity with up-to-date accuracy and safety requirements.

• Quality Assurance in Healthcare Settings
  Supports healthcare providers in selecting sphygmomanometers that meet validated clinical performance standards for intermittent automated blood pressure measurement.

Related Standards

• EN ISO 81060-1:2007
  Covers the non-invasive sphygmomanometers - Part 1: Requirements and test methods for automated measurement types. Provides foundational definitions such as bladder specifications referenced in this amendment.

• ISO 81060 series
  A series of standards addressing different aspects of sphygmomanometer design, testing, and clinical performance evaluation.

• IEC 80601-2-30
  Medical electrical equipment - Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers. Complements ISO 81060-2 by addressing electrical safety and performance.

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Keywords: non-invasive sphygmomanometer, automated blood pressure measurement, clinical investigation, limb circumference range, cuff size distribution, ISO 81060-2 amendment, blood pressure accuracy, medical device standards, sphygmomanometer validation, European standard CEN, patient safety, clinical testing protocols.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2020
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst
merjenja s prekinitvami - Dopolnilo A1 (ISO 81060-2:2018/Amd 1:2020)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent
automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden
automatisierten Bauart - Änderung 1 (ISO 81060-2:2018/Amd 1:2020)
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à
mesurage automatique - Amendement 1 (ISO 81060-2:2018/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 81060-2:2019/A1:2020
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 81060-2:2019/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Non-invasive sphygmomanometers - Part 2: Clinical
investigation of intermittent automated measurement type
- Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
Sphygmomanomètres non invasifs - Partie 2: Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische
Investigation clinique pour type ponctuel à mesurage Prüfung der intermittierenden automatisierten Bauart
automatique - Amendement 1 (ISO 81060- - Änderung 1 (ISO 81060-2:2018/Amd 1:2020)
2:2018/Amd 1:2020)
This amendment A1 modifies the European Standard EN ISO 81060-2:2019; it was approved by CEN on 17 August 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 81060-2:2019/A1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 81060-2:2018/Amd 1:2020 has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO)
and has been taken over as EN ISO 81060-2:2019/A1:2020 by Technical Committee CEN/TC 205 “Non-
active medical devices” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 81060-2:2019 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by March 2021, and
conflicting national standards shall be withdrawn at the latest by March 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 81060-2:2018/Amd 1:2020 has been approved by CEN as EN ISO 81060-
2:2019/A1:2020 without any modification.

INTERNATIONAL ISO
STANDARD 81060-2
Third edition
2018-11-29
AMENDMENT 1
2020-01
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent
automated measurement type
AMENDMENT 1
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
AMENDEMENT 1
Reference number
ISO 81060-2:2018/Amd.1:2020(E)
©
ISO 2020
ISO 81060-2:2018/Amd.1:2020(E)

© ISO 2020
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ii © ISO 2020 – All rights reserved

ISO 81060-2:2018/Amd.1:2020(E)

Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that
...