SIST EN ISO 11608-1:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user. Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively. Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.

Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 1: Nadelbasierte Injektionssysteme (ISO 11608-1:2012)

Dieser Teil der ISO 11608 legt Anforderungen und Prüfverfahren für NISs fest, die zur Verwendung mit
Nadeln und erneuerbaren oder nichterneuerbaren Behältern bestimmt sind. Die von der vorliegenden Norm
erfassten Behälter umfassen durch den Hersteller oder den Endanwender befüllte spritzenbasierte und
karpulenbasierte Systeme für eine Dosis und mehrere Dosen. Mit elektronischen oder elektromechanischen
Bauteilen ausgestattete NISs werden in dieser Norm mit Verweis auf ISO 11608-4 erfasst. Mit automatisierten
Funktionen ausgestattete NISs werden ebenfalls in dieser Norm mit Verweis auf ISO 11608-5 erfasst.
Nadellose Injektoren werden durch diese Norm nicht behandelt. Anforderungen an Verfahren und/oder
Vorrichtungen im Zusammenhang mit dem Füllen von Behältern durch den Endbenutzer werden in dieser
Norm nicht behandelt.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 1: Systèmes d'injection à aiguille (ISO 11608-1:2012)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del: Peresa za injiciranje (ISO 11608-1:2012)

Ta del standarda ISO 11608 določa zahteve in preskusne metode za peresa za injiciranje (NIS), ki naj bi se uporabljala z iglami in zamenljivimi ali nezamenljivimi posodicami. Posodice, zajete v tem delu standarda ISO 11608, vključujejo sisteme na osnovi brizge in bombic za enega ali več odmerkov, ki jih napolni proizvajalec ali končni uporabnik. Dodatna navodila za peresa za injiciranje, opremljena z elektronskimi ali elektromehanskimi sestavnimi deli, in peresa z avtomatiziranimi funkcijami so na voljo v standardu ISO 11608-4 za prva in standardu ISO 11608-5 za slednja. Peresa brez igel in zahteve glede metod ali opreme, pri katerih posodice napolni končni uporabnik, ne spadajo na področje uporabe tega dela standarda ISO 11608.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 14-Feb-2011
• Publication Date: 02-Aug-2012
• Withdrawal Date: 11-Feb-2015
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 06-Feb-2015
• Due Date: 01-Mar-2015
• Completion Date: 12-Feb-2015
• Ref Project: EN ISO 11608-1:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)

Relations

• Replaced By: SIST EN ISO 11608-1:2015 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
• Effective Date: 01-Mar-2015
• Replaces: SIST EN ISO 11608-1:2001 - Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000)
• Effective Date: 01-Sep-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11608-1:2012
11-september-2012
1DGRPHãþD
SIST EN ISO 11608-1:2001
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del:
Peresa za injiciranje (ISO 11608-1:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part
1: Needle-based injection systems (ISO 11608-1:2012)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 1: Nadelbasierte Injektionssysteme (ISO 11608-1:2012)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 1: Systèmes d'injection à aiguille (ISO 11608-1:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-1:2012
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11608-1:2012

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SIST EN ISO 11608-1:2012


EUROPEAN STANDARD
EN ISO 11608-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2012
ICS 11.040.25 Supersedes EN ISO 11608-1:2000
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 1: Needle-based injection systems (ISO
11608-1:2012)
Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 1: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil 1:
d'injection à aiguille (ISO 11608-1:2012) Nadelbasierte Injektionssysteme (ISO 11608-1:2012)
This European Standard was approved by CEN on 31 March 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a 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 European Standard 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 11608-1:2012
EN ISO 11608-1:2012 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 11608-1:2012
EN ISO 11608-1:2012 (E)
Foreword
This document (EN ISO 11608-1:2012) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and intravascular catheters" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2012, and conflicting national standards shall be withdrawn at
the latest by October 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11608-1:2000.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11608-1:2012 has been approved by CEN as a EN ISO 11608-1:2012 without any
modification.

3

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SIST EN ISO 11608-1:2012

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SIST EN ISO 11608-1:2012
INTERNATIONAL ISO
STANDARD 11608-1
Second edition
2012-04-01
Needle-based injection systems for medical
use — Requirements and test methods —
Part 1:
Needle-based injection systems
Systèmes d’injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 1: Systèmes d’injection à aiguille
Reference number
ISO 11608-1:2012(E)
©
ISO 2012

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 3
5 Requirements . 4
5.1 General . 4
5.2 System designations . 4
5.3 Risk analysis requirements . 5
5.4 Uncertainty of measurement and conformance with specifications . 5
5.5 General design requirements . 5
6 Reagent and apparatus . 7
6.1 General . 7
6.2 Test liquid . 7
6.3 Balance . 7
6.4 Test surface for free-fall testing . 7
7 Determination of dose accuracy . 7
7.1 General . 7
7.2 Dosing regions . 8
7.3 Dose settings . 8
7.4 Assessment . 9
8 Preparation and operation of NISs .12
9 Test matrix .12
10 Test descriptions .15
10.1 General .15
10.2 Cool, standard and warm atmosphere testing .15
10.3 Last-dose testing (system designations A and C only) .16
10.4 Life-cycle testing (systems designations A and B only) — Pre-conditioning .16
10.5 Free-fall testing .16
10.6 Dry-heat and cold-storage testing — Pre-conditioning .18
10.7 Damp-heat testing (system designations A and B only) — Pre-conditioning .18
10.8 Cyclical testing (system designations A and B only) — Pre-conditioning .18
10.9 Vibration testing — Pre-conditioning .18
10.10 Electromagnetic compatibility (EMC) (systems with electronics only) .19
11 Inspection .20
11.1 Visual inspection .20
11.2 Container inspection .20
11.3 Dose accuracy acceptance criteria .20
12 Test report .21
13 Information supplied by the manufacturer .22
13.1 General .22
13.2 Marking .22
13.3 Instructions for use .23
Annex A (informative) Dose replicates, accuracy and testing rationale .25
Annex B (normative) One- and two-sided tolerance limit factors, k .29
Bibliography .40
© ISO 2012 – All rights reserved iii

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11608-1 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 11608-1:2000), which has been technically revised.
ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical
use — Requirements and test methods:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers
— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
— Part 5: Automated functions
iv © ISO 2012 – All rights reserved

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
Introduction
This part of ISO 11608 covers needle-based injection systems (referred to as NISs) primarily intended for
human use. It provides performance requirements regarding essential aspects so that variations of design are
not unnecessarily restricted.
This part of ISO 11608 should be used in conjunction with the other parts of ISO 11608.
The first edition of this part of ISO 11608 introduced the concept of interchangeability and the labelling
designations “Type A” (i.e. interchangeable) and “non-Type A” for needles and container systems. Since its
promulgation, experience has shown that the complexity of these systems makes it very difficult to ensure
functional compatibility as defined in the different parts of this International Standard, particularly when products
are made by different manufacturers. Based on this experience, it is believed that the Type A designation does
not represent adequate guidance to the user in making decisions on the compatibility of needles and containers
with specific needle-based injector systems. As such, the labelling designation “Type A” has been removed.
The design requirements related to system function have been maintained as a guide to assist manufacturers
during the design phase, supporting the achievement of cross-platform compatibility. However, these design
requirements are an insufficient replacement for system testing of the components and, where possible, direct
communication and/or quality agreements between system component manufacturers. Therefore, given the
patient convenience benefits associated with cross-platform compatibility, manufacturers of needles, containers
and needle-based injectors shall label their products with the specific system components that have been
tested and demonstrated to be functionally compatible.
The sampling plans for inspection selected for this part of ISO 11608 are intended to verify the design at a high
confidence level. The sampling plans for inspection do not replace the more general manufacturing quality
systems that appear in standards on quality systems, for example the ISO 9000 series and ISO 13485.
Materials to be used for construction are not specified, as their selection will depend on the design, the intended
use and the process of manufacture used by individual manufacturers.
There are other international and national standards and guidance publications and, in some countries, national
regulations that are applicable to medical devices and pharmaceuticals. Their requirements might supersede
or complement this part of ISO 11608. Developers and manufacturers of NISs are encouraged to investigate
and determine whether there are any other requirements relevant to the safety or marketability of their products.
Manufacturers are expected to follow a risk-based approach during the design, development and manufacture
of the product. Given the specific medicinal product and intended use, this might result in product-specific
requirements and test methods that differ from what is outlined in this part of ISO 11608.
© ISO 2012 – All rights reserved v

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SIST EN ISO 11608-1:2012

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SIST EN ISO 11608-1:2012
INTERNATIONAL STANDARD ISO 11608-1:2012(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 1:
Needle-based injection systems
1 Scope
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs)
intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in
this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either
by the manufacturer or by the end-user.
Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped
with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively.
Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of
containers, are outside the scope of this part of ISO 11608.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11608 (all parts), Needle-based injection systems for medical use — Requirements and test methods
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14253-1, Geometrical Product Specifications (GPS) — Inspection by measurement of workpieces and
measuring equipment — Part 1: Decision rules for proving conformance or non-conformance with specifications
ISO 14971, Medical devices — Application of risk management to medical devices
ISO/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
measurement (GUM:1995)
IEC 60068-2-6:2007, Environmental testing — Part 2-6: Tests — Test Fc: Vibration (sinusoidal)
IEC 60068-2-30:2005, Environmental testing — Part 2-30: Tests — Test Db: Damp heat, cyclic (12 + 12 h cycle)
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 62366, Medical devices — Application of usability engineering to medical devices
© ISO 2012 – All rights reserved 1

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cap
part of the NIS intended to protect the injector and its contents
3.2
container
primary packaging that contains the medicinal product for injection (either single-compartment or multi-compartment)
3.3
dose delivery efficiency
ratio of expelled dose to fill volume
NOTE 1 Dose delivery efficiency is expressed as a percentage.
NOTE 2 Delivery efficiency can be used to evaluate dose accuracy for NISs designed to fully empty single-dose
containers filled by the user.
3.4
dialling resolution
smallest possible increment to be selected between dose amounts
3.5
dose accuracy
accuracy with which the NIS delivers a pre-set dose of medicinal product
3.6
“dose delivered” indication
dose number shown in the dose window indicating the amount of medicinal product delivered
NOTE 1 This applies to variable multi-dose NISs that allow the setting of a dose greater than the remaining volume.
NOTE 2 If the dose window indicates the amount of medicinal product yet to be delivered, then the “dose delivered”
indication can be determined as the intended dose minus the indication of medicinal product yet to be delivered.
3.7
manufacturer-filled
container supplied to the user pre-filled by the manufacturer of medicinal products
NOTE This medicinal product can be in liquid form or lyophilized with diluent in the same container.
3.8
minimum deliverable dose
minimum dose that is ensured by the manufacturer to be delivered in a single-dose manufacturer-filled NIS
designed to fully empty the container
3.9
NIS
needle-based injection system
injection system intended for parenteral administration by injection of medicinal products using a needle and a
multi-dose or single-dose container
NOTE This term may also be referred to as “system” or “injector” in this part of ISO 11608.
3.10
pre-setting
procedure by which individual amounts of medicinal product can be selected for injection by the user
NOTE The doses may be pre-set by the manufacturer or the user.
2 © ISO 2012 – All rights reserved

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
3.11
residual scale
graduated scale which indicates the remainder of medicinal product in the container
3.12
user packaging
what is provided to the user with one or a collection of devices of the same item and from the same manufacturing
batch, including the directions for use
3.13
user-filled
container that is filled or reconstituted (if in lyophilized form) by the user from a separate medicinal product or
diluent container
4 Symbols and abbreviated terms
NIS Needle-based injection system.
V One of the three pre-set doses (expressed as a volume, in millilitres) used in determining the dose
set
accuracy for a given NIS. V is defined as one of the following:
set
a)  minimum dose (V = V ) (specified in the instructions for use);
set min
b)  maximum dose (V = V ) (specified in the instructions for use);
set max
c)  midpoint dose (V = V ), where V is defined as the injector setting closest to (V + V )/2.
set mid mid min max
NOTE 1 Recommended doses as specified in the instructions for use may differ from the pre-set doses used

for determining the dose accuracy.
NOTE 2 System designations B1 and D1 define V to be equal to the manufacturer-filled or user-filled
set
volumes. System designations B2 and D2 define V to be equal to a single pre-set dose representing a portion
set
of the manufacturer-filled or user-filled volumes. In the case of last-dose accuracy assessments for system
designations A and C, V is equal to V , the TP, or dose error (evaluated over a range of doses within a
set mid
specified percentage of the TP).
V The volumetric measurement value for a given V , expressed in millilitres.
meas set
G The gravimetric measurement value for a given V , expressed in grams.
meas set
r Density, expressed in grams per millilitre.
p Probability content.
Y Number of pens required for a given test.
R Number of replicates required for a given test. A replicate is a random sequence of V , V , and
min mid
V . There are six possible replicates.
max
n
Number of measurements, V , to be made for each V .
meas set
x
The sample mean; when based on a random sample, an estimate of the true mean:

xV= /n
∑ meas
.
s The sample standard deviation; when based on a random sample, an estimate of the true standard
deviation:
12/

2
 
sV=−()xn/( −1)
∑ meas
 
.
© ISO 2012 – All rights reserved 3

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
k k value, or tolerance limit factor, determined from the confidence level (95 %), probability content, p,
and number of accuracy measurements, n, conducted at each dose setting.
k Actual k value, determined from the following equations:
act
Two-sided

 Ux− xL− 
() ()
  Min ,
 
s s
 
 

One-sided

 xL−   Ux− 
() ()
   
s s
   
   
  or

k Target k value, found from the look-up table in ISO 16269-6:2005 (Annexes D and E), or Annex B.
tar
DR Dialling resolution, the minimum dialling increment of the NIS.
a Absolute error, in millilitres, used to define the upper and lower specification limits for a pre-set dose
in absolute terms.
b Relative error, as a percentage, used to define the upper and lower specification limits for a pre-set
dose in relative terms.
TP The transition point volume, in millilitres, at which the upper and lower specification limits for V
set
change from absolute terms to relative terms (i.e. V where a and b are equal):
set
  TP = (100 × a)/b
USL Upper specification limit for a given V .
set
LSL Lower specification limit for a given V .
set
RF Radio frequency
5 Requirements
5.1 General
Companies wishing to verify a NIS shall ensure that the system meets the requirements of this part of
ISO 11608. In addition, companies shall ensure that the appropriate components (e.g. needles and containers)
and features (e.g. electromechanical drive systems and automated functions) specified for use in the system
satisfy the relevant parts of ISO 11608.
5.2 System designations
Given the differences in device designs and containers (e.g. multi-dose, single dose with partial evacuation,
and single-dose with full evacuation), the following system designations are provided to clearly associate the
appropriate test and dose accuracy method with the injection system under consideration. Containers can be
either manufacturer-filled or user-filled.
Table 1 shows the various needle-based injector system designations.
4 © ISO 2012 – All rights reserved

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SIST EN ISO 11608-1:2012
ISO 11608-1:2012(E)
Table 1 — System designations
Multi-dose container Single-dose container
A B1
Needle-based injection device with replaceable container. Needle-based injection device with replaceable container.
Each container holds multiple doses, the size of which may Each container holds a single dose, whereby the entire
be fixed or variable (pre-set by the user). deliverable volume is expelled.
B2
Needle-based injection device with replaceable container.
Each container holds a single dose, whereby a portion of
the deliverable volume is expelled.
C D1
Needle-based injection device with integrated non- Needle-based injection device with integrated non-
replaceable container. replaceable container.
Each container holds multiple doses, the size of which may Each container holds a single dose, whereby the entire
be fixed or variable (pre-set by the user). deliverable volume is expelled.
D2
Needle-based injection device with integrated non-
replaceable container.
Each container holds a single dose, whereby a portion of
the deliverable volume is expelled.
5.3 Risk analysis requirements
The manufacturer shall conduct risk assessments in accordance with ISO 14971. These risk assessments shall
consider all aspects of the development, manufacture and intended use of the NIS for medical use. The NIS
shall conform to the usability requirements specified in IEC 62366.
5.4 Uncertainty of measurement and conformance wit
...