SIST EN 60601-2-34:2014

SLOVENSKI STANDARD
SIST EN 60601-2-34:2014
01-september-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DLQYD]LYQRQDG]RURYDQMHNUYQHJDWODND,(&

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and
essential performance of invasive blood pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit
einschließlich wesentlicher Leistungsmerkmale, von invasiven Blutdruck-
Überwachungsgeräten
Appareils électromédicaux - Partie 2-34: Règles particulières de sécurité de base et de
performances essentielles pour les appareils de surveillance de la pression sanguine
prélevée directement
Ta slovenski standard je istoveten z: EN 60601-2-34:2014
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-34:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-34:2014

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SIST EN 60601-2-34:2014


EUROPEAN STANDARD EN 60601-2-34

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2014
ICS 11.040.55 Supersedes EN 60601-2-34:2000
English Version
Medical electrical equipment - Part 2-34: Particular requirements
for the basic safety and essential performance of invasive blood
pressure monitoring equipment
(IEC 60601-2-34:2011)
Appareils électromédicaux - Partie 2-34: Exigences Medizinische elektrische Geräte - Teil 2-34: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance de la pression wesentlichen Leistungsmerkmale von invasiven Blutdruck-
sanguine prélevée directement Überwachungsgeräten
(CEI 60601-2-34:2011) (IEC 60601-2-34:2011)
This European Standard was approved by CENELEC on 2011-05-16. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-34 E

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SIST EN 60601-2-34:2014
EN 60601-2-34:2014 - 2 -
Foreword
The text of document 62D/906/FDIS, future edition 3 of IEC 60601-2-34, prepared by SC 62D,
"Electromedical equipment", of IEC TC 62, "Electrical equipment in medical practice", was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-34:2014.
The following dates are fixed:
(dop) 2014-12-27
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-06-27
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-34:2000.

EN 60601-2-34:2014 was revised to align structurally with EN 60601-1:2006.

In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;

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SIST EN 60601-2-34:2014
- 3 - EN 60601-2-34:2014
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.

Endorsement notice
The text of the International Standard IEC 60601-2-34:2011 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 80601-2-30 NOTE  Harmonized as EN 80601-2-30.

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SIST EN 60601-2-34:2014
EN 60601-2-34:2014 - 4 -
Annex ZA
(normative)


Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Annex ZA of the general standard applies, except as follows:

Publication Year Title EN/HD Year

Replacement:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests


IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems


Addition:

IEC 60601-2-2 2009 Medical electrical equipment -  EN 60601-2-2 2009
 Part 2-2: Particular requirements for basic + A11 2011
safety and essential performance of high
frequency surgical equipment and high
frequency surgical accessories


1)
IEC 60601-2-27 - Medical electrical equipment - EN 60601-2-27 -
Part 2-27: Particular requirements for the
basic safety and essential performance of
electrocardiographic monitoring equipment


1)
IEC 60601-2-49 - Medical electrical equipment - EN 60601-2-49 -
Part 2-49: Particular requirements for the
basic safety and essential performance of
multifunction patient monitoring equipment


ISO 15223-1 2007 Medical devices - Symbols to be used with EN ISO 15223-1 2012
medical device labels, labelling and
information to be supplied -
Part 1: General requirements

1)
At draft stage.

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SIST EN 60601-2-34:2014
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Annex ZZ
(informative)

Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC except as follows:
– Essential Requirement 6a
– Essential Requirement 7.4
– Essential Requirement 7.5 paragraph 2 & 3
– Essential Requirement 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING - Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.

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SIST EN 60601-2-34:2014

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SIST EN 60601-2-34:2014
IEC 60601-2-34
®

Edition 3.0 2011-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-34: Particular requirements for the basic safety and essential performance
of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression sanguine prélevée
directement

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.55 ISBN 978-2-88912-495-4

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-34:2014
– 2 – 60601-2-34  IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents. 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 23
201.13 HAZARDOUS SITUATIONS and fault conditions . 29
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29
201.15 Construction of ME EQUIPMENT . 29
201.16 ME SYSTEMS . 30
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
202 Electromagnetic compatibility – Requirements and tests . 30
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 36
Annexes . 45
Annex AA (informative) Particular guidance and rationale . 46
Annex BB (informative) Alarm diagrams 208/IEC 60601-1-8:2006 . 59
Bibliography . 61
Index of defined terms used in this particular standard. 62

Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery
test . 15
Figure 201.102 – Diaphragm leak test . 16
Figure 201.103 – Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) . 17
Figure 201.104 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal
ACCESSIBLE PART that is not PROTECTIVELY EARTHED. . 18
Figure 201.105 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of INTERNALLY POWERED ME EQUIPMENT caused by an external voltage on
a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 19
Figure 201.106– Clarification of leakage current tests . 20
Figure 201.107 – Over-pressure test . 21
Figure 201.108 – Test for accuracy of pressure measurements . 25

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SIST EN 60601-2-34:2014
60601-2-34  IEC:2011 – 3 –
Figure 201.109 – Test sequence for sensitivity, repeatability, non-linearity, drift and
hysteresis . 26
Figure 201.110 – Pressure measurement system for accuracy of systolic and diastolic
pressure . 27
Figure 201.111 – Frequency response of ME EQUIPMENT and TRANSDUCER . 28
Figure 202.101 – Test layout for conducted and radiated emission and radiated
immunity test . 31
Figure 202.102 – Test circuit for high-frequency surgery interference measurement,
when the isolation of the APPLIED PART is in the monitor . 34
Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation
of the APPLIED PART is in the TRANSDUCER . 35
Figure 202.104 – Test set-up for high-frequency surgery protection . 36
Figure 208.101 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 41
Figure 208.102 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 42
Figure AA.1 – Pressure TRANSDUCER error band . 53
Figure BB.101 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 59
Figure BB.102 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 59
Figure BB.103 – LATCHING ALARM SIGNALS with ALARM RESET . 60
Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET . 60

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 10
Table 208.101 – ALARM CONDITION priorities . 37
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS . 38

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SIST EN 60601-2-34:2014
– 4 – 60601-2-34  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-34 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition of IEC 60601-2-34 published in
2001 and constitutes a technical revision. This edition was revised to align structurally with
the 2005 edition of IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/906/FDIS 62D/923/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

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SIST EN 60601-2-34:2014
60601-2-34  IEC:2011 – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 60601-2-34:2014
– 6 – 60601-2-34  IEC:2011
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE
BLOOD PRESSURE MONITORING EQUIPMENT. It amends and supplements IEC 60601-1 (third
edition, 2005): Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance, hereinafter referred to as the general standard.
The aim of this third edition is to bring this particular standard up to date with reference to the
third edition of the general standard through reformatting and technical changes.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. It is considered that knowledge of the reasons for these
requirements will not only facilitate the proper application of the standard but will, in due
course, expedite any revision necessitated by changes in clinical practice or as a result of
developments in technology. However, Annex AA does not form part of the requirements of
this standard.

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SIST EN 60601-2-34:2014
60601-2-34  IEC:2011 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 *Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE
BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter referred to as
ME EQUIPMENT.
This particular standard does not apply to catheter tubing, catheter needles, Luer locks, taps
and tap tables that connect to the DOME.
This particular standard does not apply to NON-INVASIVE BLOOD PRESSURE MONITORING
EQUIPMENT.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT, as defined in 201.3.63.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2007 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208
respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the
IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
—————————
1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

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A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended
...