Re: [PSES] IEC 60601-1-2: 2014 4th Edition

2018-04-22 Thread John Woodgate 
It depends on the opinion of the regulatory authority in the country of 
sale. In Europe(applying the EN versions), it is the manufacturer's 
responsibility to justify and document the decision on partial testing,


John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK

On 2018-04-22 06:30, itl-emc user group wrote:


Hi,

A question has arisen concerning grandfathering to the IEC 60601-1-2: 
2007 3^rd Edition.


If a device has met the requirements of IEC 60601-1-2: 2007 3^rd 
edition, is it acceptable to only test for the additional requirements 
of IEC 60601-1-2: 2014 4^th Edition? Can a manufacturer then claim 
compliance to the Edition 4?


A lot of customers only want partial testing even when full testing is 
recommended.


Opinions?

*Regards,***

*David Shidlowsky***| Technical Reviewer

*Address*1 Bat-Sheva St. LOD 7120101 Israel

*Tel*972-8-9186113*Fax* 972-8-9153101

*Mail*: dav...@itlglobal.org 
/dav...@itl.co.il 


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[PSES] IEC 60601-1-2: 2014 4th Edition

2018-04-22 Thread itl-emc user group 
Hi,
A question has arisen concerning grandfathering to the IEC 60601-1-2: 2007 3rd 
Edition.
If a device has met the requirements of IEC 60601-1-2: 2007 3rd edition, is it 
acceptable to only test for the additional requirements of IEC 60601-1-2: 2014 
4th Edition? Can a manufacturer then claim compliance to the Edition 4?
A lot of customers only want partial testing even when full testing is 
recommended.
Opinions?


Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. LOD 7120101 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail : 
dav...@itlglobal.org/dav...@itl.co.il

This e-mail message may contain privileged or confidential information.
If you are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.



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Re: [PSES] IEC-60601-1-2: 2014 (4th Edition)

2016-05-23 Thread T.Sato 
On Mon, 23 May 2016 05:22:07 +,
  itl-emc user group  wrote:

> According to Clause 5.2.2.1 "Requirements applicable to all ME EQUIPMENT and 
> ME SYSTEMS", :
> "For all ME EQUIPMENT and ME SYSTEMS, the technical description shall include 
> the following information:
> a) the compliance for each EMISSIONS and IMMUNITY standard or test specified 
> by this collateral standard, e.g. EMISSIONS class and group and IMMUNITY TEST 
> LEVEL;
> b) any deviations from this collateral standard and allowances used;
> c) * all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL 
> PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES for the EXPECTED 
> SERVICE LIFE."
> In IEC 60601-1-2: 2007, the above information was provided in the Guidance 
> and MANUFACTURER'S declaration - ELECTROMAGNETIC EMISSIONS tables.
> I did not find any similar tables in IEC 60601-1-2: 2014 .
> Any ideas on how to instruct clients to comply with Clause 5.2.2.1 a, b, c?

IEC 60601-1-2:2014 Annex A has some additional guide:

  Subclause 5.2.2.1 a), Compliance for each EMISSIONS and IMMUNITY
  standard

  This requirement replaces in part the requirements specified in
  Edition 3 to include tables of compliance levels and EMC guidance in
  the ACCOMPANYING DOCUMENTS. While a MANUFACTURER can choose to put
  the information in such a format, this collateral standard does not
  mandate the format for this information. ...

Regards,
Tom

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[PSES] IEC-60601-1-2: 2014 (4th Edition)

2016-05-23 Thread itl-emc user group 
Hello,
According to Clause 5.2.2.1 "Requirements applicable to all ME EQUIPMENT and ME 
SYSTEMS", :
"For all ME EQUIPMENT and ME SYSTEMS, the technical description shall include 
the following information:
a) the compliance for each EMISSIONS and IMMUNITY standard or test specified by 
this collateral standard, e.g. EMISSIONS class and group and IMMUNITY TEST 
LEVEL;
b) any deviations from this collateral standard and allowances used;
c) * all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL 
PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES for the EXPECTED 
SERVICE LIFE."
In IEC 60601-1-2: 2007, the above information was provided in the Guidance and 
MANUFACTURER'S declaration - ELECTROMAGNETIC EMISSIONS tables.
I did not find any similar tables in IEC 60601-1-2: 2014 .
Any ideas on how to instruct clients to comply with Clause 5.2.2.1 a, b, c?
Thanks in advance for any responses

Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. LOD 7120101 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail dav...@itl.co.il/e...@itl.co.il  Web 
www.itl.co.il

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