SIST EN 303 203-2 V1.1.1:2014
(Main)Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range - Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
General Information
- Abstract
Development of harmonised standard for Medical Body Area Network Systems operating in the 2483,5 MHz to 2500 MHz range, covering the essential requirements of article 3.2 of the R&TTE Directive. The standard will address the request by CEPT WGFM in document ERM(13)49b017, that to improve compatibility between MBANS and LP-AMI adequate spectrum sharing mechanisms will be investigated.
- Status
- Published
- Public Enquiry End Date
- 29-Oct-2014
- Publication Date
- 23-Nov-2014
- Technical Committee
- MOC - Mobile Communications
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 10-Nov-2014
- Due Date
- 15-Jan-2015
- Completion Date
- 24-Nov-2014
- Mandate
- M/284
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ETSI EN 303 203-2 V1.1.0 (2014-07) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
ETSI EN 303 203-2 V1.1.1 (2014-11) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
Overview
SIST EN 303 203-2 V1.1.1:2014 is a harmonized European standard developed by the Slovenski inštitut za standardizacijo (SIST) in partnership with ETSI. It specifies the essential requirements for Medical Body Area Network Systems (MBANSs) operating in the 2 483.5 MHz to 2 500 MHz frequency range in accordance with article 3.2 of the R&TTE Directive. This standard addresses electromagnetic compatibility and radio spectrum requirements for short-range medical devices, particularly focusing on spectrum sharing and interference mitigation between MBANS and other users, such as Low Power Active Medical Implants (LP-AMI).
The standard applies to MBANS equipment used in healthcare facilities and patient homes, including on-body and off-body medical sensors, patient monitoring systems, and medical actuators as outlined under the Medical Device Directive.
Key Topics
- Electromagnetic Compatibility (EMC): Ensures that MBANS devices meet strict EMC parameters to minimize the risk of interference with other wireless systems and ensure safe operation in sensitive medical environments.
- Radio Spectrum Usage: Defines how these devices operate within the specified frequency band, supporting effective coexistence with other short-range devices and wireless networks.
- Conformance and Testing: Details the technical characteristics, conformance requirements, and essential radio test suites for demonstrating compliance, including transmitter and receiver requirements.
- Spectrum Sharing Mechanisms: Addresses the need for adequate spectrum sharing and compatibility mechanisms between MBANS and other technologies (e.g., LP-AMI), in accordance with CEPT recommendations.
- Environmental Profile: Specifies the environmental conditions under which devices must conform to these requirements.
- Regulatory Alignment: Enables manufacturers and operators to demonstrate compliance with the R&TTE Directive, facilitating approvals and market access within the European Union.
Applications
Medical Body Area Network Systems (MBANSs) are used for:
- Continuous patient monitoring in hospitals and clinics via wireless medical sensors.
- Remote patient health monitoring in homecare settings.
- Wireless data collection from implantable and wearable medical devices.
- Supporting advanced e-health and telemedicine solutions requiring reliable, standardized short-range communication.
By adhering to this standard, manufacturers and healthcare providers ensure that medical wireless devices:
- Operate within clearly defined radio parameters, reducing the risk of harmful interference.
- Meet interoperability and safety requirements needed for both hospital and home healthcare environments.
- Comply with European regulations, simplifying the certification and deployment process.
Related Standards
Several standards and regulations complement SIST EN 303 203-2 V1.1.1:2014, supporting the medical device and wireless communication ecosystem:
- EN 303 203-1: Technical characteristics and test methods for MBANS operating in the 2 483.5 MHz to 2 500 MHz range.
- TR 101 557: System reference document for MBANS in the 1 785 MHz to 2 500 MHz frequency range.
- CEPT/ERC/REC 70-03: Use of short-range devices across Europe.
- ETSI TR 100 028: Measurement uncertainties for mobile radio equipment.
- Directive 1999/5/EC (R&TTE Directive): Framework for radio equipment and mutual recognition of conformity.
- Directive 93/42/EEC: European regulation for medical devices.
SIST EN 303 203-2 is essential for stakeholders in medical wireless technology, device manufacturers, and regulatory professionals who require robust, harmonized guidelines to ensure safe, reliable, and compliant operation of medical body area networks in the critical 2.4 GHz spectrum range.
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ETSI EN 303 203-2 V1.1.0 (2014-07) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
ETSI EN 303 203-2 V1.1.1 (2014-11) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
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Frequently Asked Questions
SIST EN 303 203-2 V1.1.1:2014 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range - Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive". This standard covers: Development of harmonised standard for Medical Body Area Network Systems operating in the 2483,5 MHz to 2500 MHz range, covering the essential requirements of article 3.2 of the R&TTE Directive. The standard will address the request by CEPT WGFM in document ERM(13)49b017, that to improve compatibility between MBANS and LP-AMI adequate spectrum sharing mechanisms will be investigated.
Development of harmonised standard for Medical Body Area Network Systems operating in the 2483,5 MHz to 2500 MHz range, covering the essential requirements of article 3.2 of the R&TTE Directive. The standard will address the request by CEPT WGFM in document ERM(13)49b017, that to improve compatibility between MBANS and LP-AMI adequate spectrum sharing mechanisms will be investigated.
SIST EN 303 203-2 V1.1.1:2014 is classified under the following ICS (International Classification for Standards) categories: 33.060.99 - Other equipment for radiocommunications; 33.100.01 - Electromagnetic compatibility in general; 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 303 203-2 V1.1.1:2014 is associated with the following European legislation: EU Directives/Regulations: 1999/5/EC; Standardization Mandates: M/284. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 303 203-2 V1.1.1:2014 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
Draft ETSI EN 303 203-2 V1.1.0 (2014-07)
HARMONIZED EUROPEAN STANDARD
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Medical Body Area Network Systems (MBANSs) operating in
the 2 483,5 MHz to 2 500 MHz range;
Part 2: Harmonized EN covering the essential requirements
of article 3.2 of the R&TTE Directive
2 Draft ETSI EN 303 203-2 V1.1.0 (2014-07)
Reference
DEN/ERM-TG30-305
Keywords
health, network, radio, regulation, SRD, system
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00 Fax: +33 4 93 65 47 16
Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88
Important notice
The present document can be downloaded from:
http://www.etsi.org
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2014.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
3 Draft ETSI EN 303 203-2 V1.1.0 (2014-07)
Contents
Intellectual Property Rights . 5
Foreword . 5
Modal verbs terminology . 5
Introduction . 6
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions, symbols and abbreviations . 8
3.1 Definitions . 8
3.2 Symbols . 8
3.3 Abbreviations . 8
4 Technical requirements and specifications . 8
4.1 Environmental profile . 8
4.2 Conformance requirements . 8
4.2.1 Transmitter requirements . 8
4.2.1.1 Frequency Error . 8
4.2.1.1.1 Definition. 8
4.2.1.1.2 Limits . 9
4.2.1.1.3 Conformance . 9
4.2.1.2 Emission bandwidth . 9
4.2.1.2.1 Definition. 9
4.2.1.2.2 Limits . 9
4.2.1.2.3 Conformance . 9
4.2.1.3 Effective isotropic radiated power . 9
4.2.1.3.1 Definition. 9
4.2.1.3.2 Limits . 9
4.2.1.3.3 Conformance . 9
4.2.1.4 Spurious emissions . 9
4.2.1.4.1 Definition. 9
4.2.1.4.2 Limits . 9
4.2.1.4.3 Conformance . 9
4.2.1.5 Out-of-band emissions . 9
4.2.1.5.1 Definition. 9
4.2.1.5.2 Limits . 10
4.2.1.5.3 Conformance . 10
4.2.1.6 Frequency stability under low voltage conditions . 10
4.2.1.6.1 Definition. 10
4.2.1.6.2 Limits . 10
4.2.1.6.3 Conformance . 10
4.2.1.7 Duty cycle . 10
4.2.1.7.1 Definition. 10
4.2.1.7.2 Limits . 10
4.2.1.7.3 Conformance . 10
4.2.2 Receiver requirements . 10
4.2.2.1 Spurious radiation . 10
4.2.2.1.1 Definition. 10
4.2.2.1.2 Limits . 10
4.2.2.1.3 Conformance . 10
4.2.3 Spectrum access . 11
4.2.3.1 Definition . 11
4.2.3.2 Limits . 11
4.2.3.3 Conformance . 11
ETSI
4 Draft ETSI EN 303 203-2 V1.1.0 (2014-07)
5 Testing for compliance with technical requirements . 11
5.1 Environmental conditions for testing . 11
5.1.1 Presentation for testing . 11
5.1.2 Test conditions . 11
5.2 Interpretation of the measurement results . 11
5.3 Essential radio test suites . 12
5.3.1 Frequency error . 12
5.3.2 Emission bandwidth . 12
5.3.3 Effective isotropic radiated power . 12
5.3.4 Transmitter spurious emis sions . 12
5.3.5 Out-of-band emissions . 12
5.3.6 Frequency stability under low voltage conditions . 12
5.3.7 Receiver spurious emissions . 12
5.3.8 Spectrum access . 12
5.3.9 Normal test-conditions . 12
5.3.10 Extreme test-conditions . 12
5.3.11 Test power source . 12
5.3.12 Choice of samples for test suites . 12
Annex A (normative): HS Requirements and conformance Test specifications Table
(HS-RTT) . 13
Annex B (informative): Change History . 15
Annex C (informative): Bibliography . 16
History . 17
ETSI
5 Draft ETSI EN 303 203-2 V1.1.0 (2014-07)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://ipr.etsi.org).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This draft Harmonized European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM), and is now submitted for the combined Public Enquiry and Vote
phase of the ETSI standards EN Approval Procedure.
For non EU countries the present document may be used for regulatory (Type Approval) purposes.
The present document has been produced by ETSI in response to mandate M/284 issued from the European
Commission under Directive 98/34/EC [i.7] as amended by Directive 98/48/EC [i.6].
The title and reference to the present document are intended to be included in the publication in the Official Journal of
the European Union of titles and references of Harmonized Standard under the Directive 1999/5/EC [i.3].
See article 5.1 of Directive 1999/5/EC [i.3] for information on presumption of conformity and Harmonized Standards or
parts thereof the references of which have been published in the Official Journal of the European Union.
The requirements relevant to Directive 1999/5/EC [i.3] are summarized in annex A.
The present document is part 2 of a multi-part deliverable covering Medical Body Area Network Systems (MBANSs)
operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document for the equipment,
TR 101 557 [i.1], and as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".
Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa
Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "may not", "need", "need not", "will",
"will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms
for the expression of provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
ETSI
6 Draft ETSI EN 303 203-2 V1.1.0 (2014-07)
Introduction
The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to
cover all radio and telecommunications termi
...
HARMONIZED EUROPEAN STANDARD
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Short Range Devices (SRD);
Medical Body Area Network Systems (MBANSs)
operating in the 2 483,5 MHz to 2 500 MHz range;
Part 2: Harmonized EN covering the essential requirements
of article 3.2 of the R&TTE Directive
2 ETSI EN 303 203-2 V1.1.1 (2014-11)
Reference
DEN/ERM-TG30-305
Keywords
health, network, radio, regulation, SRD, system
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00 Fax: +33 4 93 65 47 16
Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88
Important notice
The present document can be downloaded from:
http://www.etsi.org
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2014.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
3 ETSI EN 303 203-2 V1.1.1 (2014-11)
Contents
Intellectual Property Rights . 5
Foreword . 5
Modal verbs terminology . 5
Introduction . 6
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions, symbols and abbreviations . 8
3.1 Definitions . 8
3.2 Symbols . 8
3.3 Abbreviations . 8
4 Technical requirements and specifications . 8
4.1 Environmental profile . 8
4.2 Conformance requirements . 8
4.2.1 Transmitter requirements . 8
4.2.1.1 Frequency Error . 8
4.2.1.1.1 Definition. 8
4.2.1.1.2 Limits . 9
4.2.1.1.3 Conformance . 9
4.2.1.2 Emission bandwidth . 9
4.2.1.2.1 Definition. 9
4.2.1.2.2 Limits . 9
4.2.1.2.3 Conformance . 9
4.2.1.3 Effective isotropic radiated power . 9
4.2.1.3.1 Definition. 9
4.2.1.3.2 Limits . 9
4.2.1.3.3 Conformance . 9
4.2.1.4 Spurious emissions . 9
4.2.1.4.1 Definition. 9
4.2.1.4.2 Limits . 9
4.2.1.4.3 Conformance . 9
4.2.1.5 Out-of-band emissions . 9
4.2.1.5.1 Definition. 9
4.2.1.5.2 Limits . 10
4.2.1.5.3 Conformance . 10
4.2.1.6 Frequency stability under low voltage conditions . 10
4.2.1.6.1 Definition. 10
4.2.1.6.2 Limits . 10
4.2.1.6.3 Conformance . 10
4.2.1.7 Duty cycle . 10
4.2.1.7.1 Definition. 10
4.2.1.7.2 Limits . 10
4.2.1.7.3 Conformance . 10
4.2.2 Receiver requirements . 10
4.2.2.1 Spurious radiation . 10
4.2.2.1.1 Definition. 10
4.2.2.1.2 Limits . 10
4.2.2.1.3 Conformance . 10
4.2.3 Spectrum access . 11
4.2.3.1 Definition . 11
4.2.3.2 Limits . 11
4.2.3.3 Conformance . 11
ETSI
4 ETSI EN 303 203-2 V1.1.1 (2014-11)
5 Testing for compliance with technical requirements . 11
5.1 Environmental conditions for testing . 11
5.1.1 Presentation for testing . 11
5.1.2 Test conditions . 11
5.2 Interpretation of the measurement results . 11
5.3 Essential radio test suites . 12
5.3.1 Frequency error . 12
5.3.2 Emission bandwidth . 12
5.3.3 Effective isotropic radiated power . 12
5.3.4 Transmitter spurious emis sions . 12
5.3.5 Out-of-band emissions . 12
5.3.6 Frequency stability under low voltage conditions . 12
5.3.7 Receiver spurious emissions . 12
5.3.8 Spectrum access . 12
5.3.9 Normal test-conditions . 12
5.3.10 Extreme test-conditions . 12
5.3.11 Test power source . 12
5.3.12 Choice of samples for test suites . 12
Annex A (normative): HS Requirements and conformance Test specifications Table
(HS-RTT) . 13
Annex B (informative): Change History . 15
Annex C (informative): Bibliography . 16
History . 17
ETSI
5 ETSI EN 303 203-2 V1.1.1 (2014-11)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://ipr.etsi.org).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This Harmonized European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM).
For non EU countries the present document may be used for regulatory (Type Approval) purposes.
The present document has been produced by ETSI in response to mandate M/284 issued from the European
Commission under Directive 98/34/EC [i.7] as amended by Directive 98/48/EC [i.6].
The title and reference to the present document are intended to be included in the publication in the Official Journal of
the European Union of titles and references of Harmonized Standard under the Directive 1999/5/EC [i.3].
See article 5.1 of Directive 1999/5/EC [i.3] for information on presumption of conformity and Harmonized Standards or
parts thereof the references of which have been published in the Official Journal of the European Union.
The requirements relevant to Directive 1999/5/EC [i.3] are summarized in annex A.
The present document is part 2 of a multi-part deliverable covering Medical Body Area Network Systems (MBANSs)
operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document for the equipment,
TR 101 557 [i.1], and as identified below:
Part 1: "Technical characteristics and test methods";
Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates
Date of adoption of this EN: 30 October 2014
Date of latest announcement of this EN (doa): 31 January 2015
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 July 2015
Date of withdrawal of any conflicting National Standard (dow): 31 July 2016
Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "may not", "need", "need not", "will",
"will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms
for the expression of provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
ETSI
6 ETSI EN 303 203-2 V1.1.1 (2014-11)
Introduction
The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to
cover all radio and telecommunications terminal equipment within the scope of the R&TTE Directive [i.
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.RY577(Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range - Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:EN 303 203-2 Version 1.1.1SIST EN 303 203-2 V1.1.1:2014en01-december-2014SIST EN 303 203-2 V1.1.1:2014SLOVENSKI
STANDARD
operating in the 2 483,5 MHz to 2 500 MHz range; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
HARMONIZED EUROPEAN STANDARD SIST EN 303 203-2 V1.1.1:2014
ETSI ETSI EN 303 203-2 V1.1.1 (2014-11) 2
Reference DEN/ERM-TG30-305 Keywords health, network, radio, regulation, SRD, system ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00
Fax: +33 4 93 65 47 16
Siret N° 348 623 562 00017 - NAF 742 C Association à but non lucratif enregistrée à la Sous-Préfecture de Grasse (06) N° 7803/88
Important notice The present document can be downloaded from: http://www.etsi.org The present document may be made available in electronic versions and/or in print. The content of any electronic and/or print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the current status of this and other ETSI documents is available at http://portal.etsi.org/tb/status/status.asp If you find errors in the present document, please send your comment to one of the following services: http://portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm except as authorized by written permission of ETSI. The content of the PDF version shall not be modified without the written authorization of ETSI. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2014. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association. SIST EN 303 203-2 V1.1.1:2014
ETSI ETSI EN 303 203-2 V1.1.1 (2014-11) 3 Contents Intellectual Property Rights . 5 Foreword . 5 Modal verbs terminology . 5 Introduction . 6 1 Scope . 7 2 References . 7 2.1 Normative references . 7 2.2 Informative references . 7 3 Definitions, symbols and abbreviations . 8 3.1 Definitions . 8 3.2 Symbols . 8 3.3 Abbreviations . 8 4 Technical requirements and specifications . 8 4.1 Environmental profile . 8 4.2 Conformance requirements . 8 4.2.1 Transmitter requirements . 8 4.2.1.1 Frequency Error . 8 4.2.1.1.1 Definition. 8 4.2.1.1.2 Limits . 9 4.2.1.1.3 Conformance . 9 4.2.1.2 Emission bandwidth . 9 4.2.1.2.1 Definition. 9 4.2.1.2.2 Limits . 9 4.2.1.2.3 Conformance . 9 4.2.1.3 Effective isotropic radiated power . 9 4.2.1.3.1 Definition. 9 4.2.1.3.2 Limits . 9 4.2.1.3.3 Conformance . 9 4.2.1.4 Spurious emissions . 9 4.2.1.4.1 Definition. 9 4.2.1.4.2 Limits . 9 4.2.1.4.3 Conformance . 9 4.2.1.5 Out-of-band emissions . 9 4.2.1.5.1 Definition. 9 4.2.1.5.2 Limits . 10 4.2.1.5.3 Conformance . 10 4.2.1.6 Frequency stability under low voltage conditions . 10 4.2.1.6.1 Definition. 10 4.2.1.6.2 Limits . 10 4.2.1.6.3 Conformance . 10 4.2.1.7 Duty cycle . 10 4.2.1.7.1 Definition. 10 4.2.1.7.2 Limits . 10 4.2.1.7.3 Conformance . 10 4.2.2 Receiver requirements . 10 4.2.2.1 Spurious radiation . 10 4.2.2.1.1 Definition. 10 4.2.2.1.2 Limits . 10 4.2.2.1.3 Conformance . 10 4.2.3 Spectrum access . 11 4.2.3.1 Definition . 11 4.2.3.2 Limits . 11 4.2.3.3 Conformance . 11 SIST EN 303 203-2 V1.1.1:2014
ETSI ETSI EN 303 203-2 V1.1.1 (2014-11) 4 5 Testing for compliance with technical requirements . 11 5.1 Environmental conditions for testing . 11 5.1.1 Presentation for testing . 11 5.1.2 Test conditions . 11 5.2 Interpretation of the measurement results . 11 5.3 Essential radio test suites . 12 5.3.1 Frequency error . 12 5.3.2 Emission bandwidth . 12 5.3.3 Effective isotropic radiated power . 12 5.3.4 Transmitter spurious emissions . 12 5.3.5 Out-of-band emissions . 12 5.3.6 Frequency stability under low voltage conditions . 12 5.3.7 Receiver spurious emissions . 12 5.3.8 Spectrum access . 12 5.3.9 Normal test-conditions . 12 5.3.10 Extreme test-conditions . 12 5.3.11 Test power source . 12 5.3.12 Choice of samples for test suites . 12 Annex A (normative): HS Requirements and conformance Test specifications Table (HS-RTT) . 13 Annex B (informative): Change History . 15 Annex C (informative): Bibliography . 16 History . 17
ETSI ETSI EN 303 203-2 V1.1.1 (2014-11) 5 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (http://ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This Harmonized European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). For non EU countries the present document may be used for regulatory (Type Approval) purposes. The present document has been produced by ETSI in response to mandate M/284 issued from the European Commission under Directive 98/34/EC [i.7] as amended by Directive 98/48/EC [i.6]. The title and reference to the present document are intended to be included in the publication in the Official Journal of the European Union of titles and references of Harmonized Standard under the Directive 1999/5/EC [i.3]. See article 5.1 of Directive 1999/5/EC [i.3] for information on presumption of conformity and Harmonized Standards or parts thereof the references of which have been published in the Official Journal of the European Union. The requirements relevant to Directive 1999/5/EC [i.3] are summarized in annex A. The present document is part 2 of a multi-part deliverable covering Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document for the equipment, TR 101 557 [i.1], and as identified below: Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 30 October 2014 Date of latest announcement of this EN (doa): 31 January 2015 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 July 2015 Date of withdrawal of any conflicting National Standard (dow): 31 July 2016
Modal verbs terminology In the present document "shall", "shall not", "should", "should not", "may", "may not", "need"
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