SIST EN ISO 8637-1:2020

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

EN-ISO 8637-1 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: - extracorporeal blood circuits; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; - reprocessing procedures and equipment.

Kardiovaskuläre Implantate und extrakorporale Système - Teil 1: Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637-1:2017)

Diese Internationale Norm legt Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren, nachstehend zusammenfassend als „das Gerät“ bezeichnet, für die Anwendung beim Menschen fest.
Diese Internationale Norm gilt nicht für:
   extrakorporale Blutkreisläufe;
   Plasmafilter;
   Hämoperfusionsgeräte;
   Geräte für den vaskulären Zugang;
   Blutpumpen;
   Druckaufzeichnungsgeräte für extrakorporale Blutkreisläufe;
   Luftnachweisgeräte;
   Systeme für die Herstellung, Aufbewahrung oder Überwachung der Dialyseflüssigkeit;
   Systeme und Geräte für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzentration;
   Verfahren und Ausrüstung für die Wiederaufbereitung.
ANMERKUNG   Anforderungen an den extrakorporalen Blutkreislauf für Hämodialysatoren, Hämodiafilter und Hämofilter sind in ISO 8637-2 festgelegt.

Systèmes extracorporels pour la purification du sang - Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO 8637-1:2017)

L'ISO 8637-1:2017 spécifie les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs, collectivement appelés ci-après «dispositifs», utilisables chez l'homme.
L'ISO 8637-1:2017 ne s'applique pas:
-      aux circuits sanguins extracorporels;
-      aux filtres pour plasma;
-      aux dispositifs d'hémoperfusion;
-      aux dispositifs d'accès vasculaire;
-      aux pompes sanguines;
-      aux moniteurs de pression du circuit sanguin extracorporel;
-      aux dispositifs de détection d'air;
-      aux systèmes de préparation, de conservation ou de contrôle du liquide de dialyse;
-      aux systèmes ou à l'équipement destinés à effectuer une hémodialyse, une hémodiafiltration, une hémofiltration ou une hémoconcentration;
-      aux modes opératoires et au matériel de retraitement.
NOTE       Les exigences relatives au circuit sanguin extracorporel pour les hémodialyseurs, hémodiafiltres et hémofiltres sont spécifiées dans l'ISO 8637‑2.

Zunajtelesni pretočni sistemi za čiščenje krvi - 1. del: Hemodializatorji, hemodiafiltri, hemofiltri in hemokoncentratorji (ISO 8637-1:2017)

General Information

• Status: Published
• Public Enquiry End Date: 29-Jun-2016
• Publication Date: 17-May-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-Apr-2020
• Due Date: 28-Jun-2020
• Completion Date: 18-May-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 8637-1:2020 - Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

Relations

• Replaces: SIST EN ISO 8637:2014 - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
• Effective Date: 01-Jun-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8637-1:2020
01-junij-2020
Nadomešča:
SIST EN ISO 8637:2014
Zunajtelesni pretočni sistemi za čiščenje krvi - 1. del: Hemodializatorji,
hemodiafiltri, hemofiltri in hemokoncentratorji (ISO 8637-1:2017)
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators (ISO 8637-1:2017)
Kardiovaskuläre Implantate und extrakorporale Système - Teil 1: Hämodialysatoren,
Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637-1:2017)
Systèmes extracorporels pour la purification du sang - Partie 1: Hémodialyseurs,
hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO 8637-1:2017)
Ta slovenski standard je istoveten z: EN ISO 8637-1:2020
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 8637-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8637-1:2020

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SIST EN ISO 8637-1:2020


EN ISO 8637-1
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2020
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 8637:2014
English Version

Extracorporeal systems for blood purification - Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (ISO 8637-1:2017)
Systèmes extracorporels pour la purification du sang - Kardiovaskuläre Implantate und extrakorporale
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres Système - Teil 1: Hämodialysatoren, Hämodiafilter,
et hémoconcentrateurs (ISO 8637-1:2017) Hämofilter und Hämokonzentratoren (ISO 8637-
1:2017)
This European Standard was approved by CEN on 8 April 2020.

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, 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 8637-1:2020 E
worldwide for CEN national Members.

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SIST EN ISO 8637-1:2020
EN ISO 8637-1:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 8637-1:2020
EN ISO 8637-1:2020 (E)
European foreword
This document (EN ISO 8637-1:2020) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" 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 2020, and conflicting national standards shall
be withdrawn at the latest by April 2023.
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.
This document supersedes EN ISO 8637:2014.
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 8637-1:2017 has been approved by CEN as EN ISO 8637-1:2020 without any
modification.


3

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SIST EN ISO 8637-1:2020
INTERNATIONAL ISO
STANDARD 8637-1
First edition
2017-11
Extracorporeal systems for blood
purification —
Part 1:
Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
Reference number
ISO 8637-1:2017(E)
©
ISO 2017

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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)

Contents  Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 4
4.1 Biological safety . 4
4.2 Sterility . 4
4.3 Non-pyrogenicity . 4
4.4 Mechanical characteristics. 4
4.4.1 Structural integrity . 4
4.4.2 Blood compartment integrity . 5
4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports . 5
4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports . 8
4.4.5 Haemofilter filtrate ports . 8
4.4.6 Haemoconcentrator blood and filtrate ports . 8
4.5 Performance characteristics. 8
4.5.1 Solute clearance of haemodialysers and haemodiafilters . 8
4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators . 9
4.5.3 Ultrafiltration coefficient . 9
4.5.4 Volume of the blood compartment . 9
4.5.5 Pressure drop of the blood compartment . 9
4.6 Expiry date. 9
5 Test methods . 9
5.1 General . 9
5.2 Biological safety .10
5.3 Sterility .10
5.4 Non-pyrogenicity .10
5.5 Mechanical characteristics.10
5.5.1 Structural integrity .10
5.5.2 Blood compartment integrity .11
5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports .11
5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports .11
5.5.5 Haemofilter filtrate ports .11
5.5.6 Haemoconcentrator blood and filtrate ports .11
5.6 Performance characteristics.13
5.6.1 Clearance .13
5.6.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators .15
5.6.3 Ultrafiltration coefficient .16
5.6.4 Volume of the blood compartment .17
5.6.5 Pressure drop of the blood compartment .17
5.7 Expiry date.17
6  Labelling .17
6.1 Labelling on the device .17
6.2 Labelling on unit containers .18
6.3 Labelling on the outer containers.18
6.4 Information to be given in the accompanying documentation .19
Bibliography .22
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems.
This first edition of ISO 8637-1:2017 cancels and replaces the third edition of ISO 8637:2010 and
ISO 8637:2010/Amd1:2013, which has been technically revised. The following changes have been done:
— Figure 1, Figure 2, and Figure 3 have been revised.
A list of all the parts in the ISO 8637 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

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Introduction
This document is concerned with devices intended for haemodialysis, haemodiafiltration,
haemofiltration and haemoconcentration in humans. The requirements specified in this document will
help to ensure safety and satisfactory function.
It was not found practicable to specify materials of construction. This document therefore requires
only that materials which have been used have been tested and that the methods and results are
made available upon request. There is no intention to specify, or to set limits on, the performance
characteristics of the devices because such restrictions are unnecessary for the qualified user and
would limit the alternatives available when choosing a device for a specific application.
The dimensions of the blood ports and the dialysis fluid or filtrate ports have been specified to ensure
compatibility of the device with the extracorporeal blood circuit specified in ISO 8637-2. The design and
dimensions have been selected in order to minimize the risk of leakage of blood and the ingress of air.
This document reflects the consensus of physicians, manufacturers and other interested parties for
devices that are approved for clinical use. Conformance with this document is voluntary and it does not
supersede any national regulation.
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SIST EN ISO 8637-1:2020
INTERNATIONAL STANDARD ISO 8637-1:2017(E)
Extracorporeal systems for blood purification —
Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1 Scope
WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration;
— reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and
haemofilters are specified in ISO 8637-2.
2  Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
blood compartment
part of a haemodialyser (3.12), haemodiafilter (3.10), haemofilter (3.14) or haemoconcentrator (3.9)
through which blood is intended to pass
Note 1 to entry: For hollow-fibre devices, the blood compartment includes the volume of the hollow fibres plus
the headers.
3.2
clearance
volume of a solution from which a solute is completely removed per unit time
3.3
convection
transport of solutes across a semipermeable membrane, along with filtered fluid, caused by a pressure
gradient or pressure differential across the membrane
3.4
dialysis fluid
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange
solutes with blood during haemodialysis (3.13) or haemodiafiltration (3.11)
Note 1 to entry: The term “dialysis fluid” is used throughout this document to mean the fluid (made from dialysis
water and concentrates) which is delivered to the haemodialyser or haemodiafilter by a dialysis fluid delivery
system. Phrases such as “dialysate”, “dialysis solution” or “dialysing fluid” can be used in place of dialysis fluid.
Note 2 to entry: The dialysis fluid entering the haemodialyser or haemodiafilter is referred to as “fresh dialysis
fluid”, while the fluid leaving the haemodialyser or haemodiafilter is referred to as “spent dialysis fluid”.
Note 3 to entry: Dialysis fluid does not include pre-packaged parenteral fluids used in some renal replacement
therapies, such as haemodiafiltration and haemofiltration.
3.5
dialysis fluid compartment
part of a haemodialyser (3.12) or haemodiafilter (3.10) through which dialysis fluid (3.4) is intended to pass
3.6
diffusion
transport of solutes across a semipermeable membrane, caused by a concentration gradient
3.7
filtrate
fluid removed from the blood across the semipermeable membrane into the dialysis fluid or filtrate
compartment of a haemodialyser (3.12), haemodiafilter (3.10), haemofilter (3.14) or haemoconcentrator
(3.9), due to a pressure gradient (including the contributions of both hydrostatic and oncotic pressures)
across the semipermeable membrane
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3.8
haemoconcentration
process whereby plasma water and electrolytes are removed from diluted blood across a semipermeable
membrane
3.9
haemoconcentrator
device intended to perform haemoconcentration (3.8)
3.10
haemodiafilter
device intended to perform haemodiafiltration (3.11)
3.11
haemodiafiltration
form of renal replacement therapy in which the waste solutes are removed from blood by a combination
of diffusion and enhanced convection through a high flux or high permeability membrane
Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid stream as in haemodialysis. Enhanced
convective solute removal is achieved by adding ultrafiltration in excess of that needed to achieve the desired
weight loss; fluid balance is maintained by the infusion of a replacement solution into the blood circuit either
before (predilution haemodiafiltration) or after (post-dilution haemodiafiltration) or a combination of the two
(mixed dilution haemodiafiltration).
3.12
haemodialyser
device intended to perform haemodialysis (3.13)
3.13
haemodialysis
form of renal replacement therapy in which waste solutes from the blood are removed primarily by
diffusion across a semi permeable membrane contained in a haemodialyser in which the blood flows on
one side of the membrane and dialysis fluid flowing on the other
Note 1 to entry: Fluid removal that is sufficient to achieve the desired weight loss is achieved by a hydrostatic
pressure gradient across the membrane. This fluid removal provides some additional solute removal particularly
for higher molecular weight compounds.
3.14
haemofilter
device intended to perform haemofiltration (3.15)
3.15
haemofiltration
a form of renal replacement therapy in which waste solutes are removed from the blood by convection
Note 1 to entry: Convective transport is achieved by ultrafiltration across a high flux membrane. Fluid balance
is maintained by the infusion of a replacement solution into the blood either before the haemofilter (predilution
haemofiltration) or after the haemofilter (post-dilution haemofiltration) or a combination of the two (mixed
dilution haemofiltration).
Note 2 to entry: In haemofiltration there is no dialysis fluid stream.
3.16
labelling
written, printed, graphic or electronic matter that is affixed to a medical device or any of its containers
or wrappers, or accompanies a medical device and which is related to identification, technical
description and use of that medical device, but excluding shipping documents
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3.17
sieving coefficient
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in
the plasma
3.18
transmembrane pressure
TMP
p
TM
mean pressure exerted across a semipermeable membrane
Note 1 to entry: For practical reasons, the mean TMP is generally expressed as either:
— the difference between arithmetic means of inlet and outlet pressures of the blood and dialysis fluid
compartments of a haemodialyser or a haemodiafilter
or
— the difference between the arithmetic mean of the inlet and outlet pressures of the blood compartment and
the filtrate pressure of a haemofilter or a haemoconcentrator
3.19
ultrafiltration coefficient
permeability of membrane to water, generally expressed in millilitres per hour per millimetre of mercury
4  Requirements
4.1  Biological safety
Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated
for freedom from biological hazards, in accordance with 5.2. If the device is labelled for reuse, testing
shall be performed after reprocessing following the manufacturer's instructions for use.
Attention is drawn to the need to establish whether national regulations or national standards
governing toxicology and biocompatibility testing exist in the country in which the device is produced
and, if applicable, in the countries in which the device is to be marketed.
4.2  Sterility
The blood pathway of the device shall be sterile. Compliance shall be verified in accordance with 5.3.
4.3  Non-pyrogenicity
The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance
with 5.4.
4.4  Mechanical characteristics
4.4.1  Structural integrity
The device shall be capable of withstanding a positive pressure of 1,5 times the manufacturer's
recommended maximum pressure above atmospheric pressure and a negative pressure not exceeding
700 mmHg (93,3 kPa) below atmospheric pressure, when tested according to 5.5.1.
NOTE This requirement refers to the external case integrity of the device.
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4.4.2  Blood compartment integrity
When exposing the blood compartment to a validated test procedure performed at 1,5 times the
manufacturer's maximum recommended transmembrane pressure, the blood compartment shall not
leak. Compliance with this requirement shall be verified in accordance with 5.5.2.
4.4.3  Haemodialyser, haemodiafilter and haemofilter blood compartment ports
Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood circuit
are designed as an integral system, the dimensions of the blood ports shall be as given in Figure 1.
Compliance with this requirement shall be verified in accordance with 5.5.3.
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)

Key
Symbol Designation Dimension in mm Comments
α Angle of thread 15° —
β Angle of thread 15° —
γ Dimension taper rate 6:100 —
E Length of thread 10 or more —
F Length of tapered region 9 or more —
a
The superscript “a” of G means
a
G Thread pitch 8
double thread.
H Root diameter 13 or more —
1
...