Re: China Japan Regulatory Issues

1996-07-30 Thread COLON KELLY
DENTORI is Japan's Material Safety Law which calls out mandatory 
requirements for consumer products.  If a product falls under the scope 
of DENTORI, compliance is mandatory, and for some products, certification 
by MITI (Ministry of International Trade and Industry) is mandatory.  ITE 
does not fit under the scope of DENTORI.

In Japan there are no mandatory requirements for ITE equipment.  However, 
there are requirements for external computer power supplies.  They must 
meet DENTORI and requirements and require MITI Certification.  As to the 
rationale, your guess is as good as mine.

There are some voluntary schemes in Japan that may help you meet market 
requirements.  They are:

VCCI:  Japan's Voluntary Council for Control of Electromagnetic 
Interference by Data Processing Equipment and Electronic Office Equipment
VCCI certification involves emissions testing only of equipment  The 
requirements are similar to CISPR 22.

S-Mark:  This is a new voluntary scheme in Japan encompassing both safety 
and emissions requirements.  If a product does not fall under the scope 
of DENTORI and a manufacturer wants some third-party certification for 
Japan, this may be the way to go.  The certification bodies involved 
include JET and JQA .

For further information on Japan, I would suggest you contact UL's 
International Compliance Services Department in Melville.  They have a 
group of engineers who are experts in Japan's requirements.  Contact Mr. 
Hiroshi Morimoto at 516 271 6200.

Regarding China, there is a new Product Quality and the Import and Export 
Commodity Inspection Law for ITE.  Under the new system, importers must 
have a product safety mark from CCIB (Chinese State Administration of 
Import and Export Commodity  Inspection).  The certification will involve 
type testing, evaluation of the quality system and factory follow-up.  
Products without certification will be prohibited from entering the 
country.  This law will go into effect for ITE October 1996.  I received 
this information from an ITI bulletin dated July 25, 1996.  UL can 
probably assist you with this too.

I hope the above helps.

Regards,
Kelly Colon

****


Kelly Colon
Regulatory Engineering
Symbol Technologies Inc.
Voice:  516 738 3480  Fax:  516 738 3318
e-mail:  col...@symbol.com

The opinions expressed above are my own!!!



EN 60601-1

1997-03-11 Thread COLON KELLY
Hello All-

I've been trying to get some information on EN 60601-1.  The 1995 CENELEC 
catalog lists this standard, but when I called Global Engineering and BSI 
to get costs, they didn't have it on their databases.  They did have EN 
60601-1-1.  Is EN 60601-1-1 the appropriate part 1 standard?  Does EN 
60601-1 exist anymore?

Thanks in advance.

Kelly Colon
Regulatory Engineer 
Regulatory Engineering
Symbol Technologies, Inc.
phone:  516 738 3480
fax:  516 738 3318
e-mail:  col...@symbol.com


Re: Regulatory compliance training for students

1997-01-22 Thread COLON KELLY
Gabriel-

I agree with your position that regulatory work is not done only those 
with an associate's degree (I personally have a BSEE as do many of my 
colleagues).  It should be noted that even though  UL will not grant the 
title of Project Engineer to someone  without a bachelor in engineering, 
the Project Engineer and the Engineering Associate (one with an 
associate's degree) will perform the same type of project evaluations.  

Just my two cents worth.

Regards,
Kelly Colon
****
Kelly Colon
Regulatory Engineer 
Regulatory Engineering
Symbol Technologies, Inc.
phone:  516 738 3480
fax:  516 738 3318
e-mail:  col...@symbol.com

The above opinions are entirely my own!


Re: GS Mark

1997-02-25 Thread COLON KELLY
George-

The identifier for TUV PS is number '5'.  I got this information from 
Commission Communication No. 92/C210/01 dated 8-15-92, page 2 (list of 
Notified Bodies).

Regards, 
Kelly

Kelly Colon
Regulatory Engineer 
Regulatory Engineering
Symbol Technologies, Inc.
phone:  516 738 3480
fax:  516 738 3318
e-mail:  col...@symbol.com