CHAPTER 2 : EMC REGULATIONS

Administrator
Medical
Professional
Biomedical-
Engineering
Personnel
Hospital
Personnel
Title of Abstract
**
- NR -
- NR -
- NR -
European Medical Device EMC Specifications 
Randy Anderson and Michael Petsinger
*
- NR -
*
- NR -
EU Regulation of Medical Devices: Are You Ready To Comply?
Glen Dash
*
- NR -
- NR -
- NR -
Obtaining FDA Clearance For Medical Devices
Glen Dash
*
- NR -
- NR -
- NR -
Registration, Listing, And Investigation Of Medical Devices
Glen Dash
*
- NR -
- NR -
- NR -
Practical Process To Enter The European Single Market Regarding The EMC Directive
Werner Hirshi and Hubert Sauvain
*
*
***
*
Medical Device Electromagnetic Interference - ANSI Issues
Daniel D. Hoolihan
***
***
***
***
Protecting Devices From Radio-Frequency Transmitters
Dan Hoolihan
*
- NR -
- NR -
- NR -
FDA Regulatory Programs: Cooperation and Common Sense Typify A Record Of Success
Jonathan S. Kahan
*
- NR -
- NR -
- NR -
FDA's New Approach To Export Regulation
Jonathan S. Kohan
***
***
***
***
Medical Device Regulatory Requirements for Electromagnetic Compatibility
Jonathan S. Kohan
*
- NR -
- NR -
- NR -
New FDA Regulation On Reports Of Corrections And Removals
Jonathan S. Kohan
*
*
- NR -
*
Health Technical Memorandum 2014: Abatement Of Electrical Interference
Sabri Nensi
**
- NR -
- NR -
- NR -
EMI/RFI Test Equipment Focuses On Medical Device Directive
Paul O'Shea
*
- NR -
- NR -
*
The EMC Directive: A Year Later
Mike Violette
*
**
**
***
Keeping Medical Devices Safe From Electromagnetic Interference
Rebecca D. Williams

*** - Highly Relevant, ** - Moderately Relevant, * - Less Relevant, NR - Not Relevant


The following abstracts have been categorized into:

2.4.1 EMC Regulations in the United States
2.4.2 EMC Guidelines in Europe



2.4.1 EMC Regulations in the United States 


FDA REGULATORY PROGRAMS:COOPERATION AND COMMON SENSE TYPIFY A RECORD OF SUCCESS
Jonathan S. Kahan
Medical Device & Diagnostic Industry
May 1996
p 88 - 98
Full Version Of Article Reprinted With Permission From Medical Device and Diagnostic Industry. Copyright © 1996 Canon Communications LLC.

Abstract: In the twenty years since the passage of the Medical Device Amendments, the U.S. medical device industry has grown to more than $40 billion in sales and provides work to more than 300,000 employees. This growth has been accompanied by an increase in government scrutiny and several new federal regulatory requirements. In the past twenty years, FDA has worked in partnership with industry to ensure the safety and effectiveness of medical devices. However, after years of enforcing a host of burdensome regulatory requirements the FDA is now entering a more rational and moderate era of device regulation. Nevertheless the overall performance of the FDA in regulating devices reflect a record of success. This paper includes discussions on 510 (k) Premarket Notification Process, Premarket Approval Process (PMA), and Safe Medical Device Act of 1990.

Subjects: The Premarket Clearance Process; Clinical Trial Requirements; Medical Device Software; The Safe Medical Devices Act of 1990; Manufacturer and User Reporting; FDA Enforcement Initiatives; The Next 20 Years


GO BACK TO TOP 


FDA'S NEW APPROACH TO EXPORT REGULATION
Jonathan S. Kahan
Medical Device & Diagnostic Industry
September 1996
p 68 - 72
Full Version Of Article Reprinted With Permission From Medical Device and Diagnostic Industry. Copyright © 1996 Canon Communications LLC.

Abstract: The consensus among the FDA-regulated industries is that the export provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act) seem to be outdated for years. According to the FD&C Act, all medical devices not cleared through the 510(k) premarket notification process or not having obtained premarket approval can nevertheless be exported if the product abides by the specifications of the foreign purchaser, if it is not in conflict with the laws of the country to which it is intended for export, if it has a label on the outside of the shipping package stating that it is intended for export, and if it is not sold or offered for sale in domestic commerce. The FDA Export Reform and Enhancement Act of 1996 was introduced and has significantly lessened the burden on the device industry in the export of undeclared and unapproved products. There are still several issues that needs to be resolved, but the new law is definitely a step in the right direction for the U.S. medical device industry.

Subjects: Approval in Listed countries; Export of Investigational Devices; Importation and Re-export of Components; Unapproved Devices; Export Certification


GO BACK TO TOP 


HEALTH TECHNICAL MEMORANDUM 2014: ABATEMENT OF ELECTRICAL INTERFERENCE
Sabira Nensi
October 1994
p 2/1-2/4
Full Version Of Article Not Available - Permission Pending.

Abstract: This article is a summary of a HMSO document Health Technical Memorandum (HTM) 2014 called "Abatement of Electrical Interference." The HMSO documents are prepared in response to the National Health Services needs for providing satisfactory electrical services within the Health Care Premises (HCP). This article also provides information on several directives for medical devices.

Subjects: Background; Current Status; Management Policy; Design Considerations; Validation and Verification; Operational Management


GO BACK TO TOP 


KEEPING MEDICAL DEVICES SAFE FROM ELECTROMAGNETIC INTERFERENCE
Rebecca D. Williams
FDA Consumer
May 1995
p 13 - 16
Full Version Of Article Not Available - Permission Pending.

Abstract: Between 1979 and 1993, the FDA received reports of more than 100 suspected incidents of EMI with medical devices. This article presents a selection of these reported incidents and provides a list of FDA recommendations for consumers and health professionals regarding protection from unwanted interference.

Subjects: What Consumers Can Do

Note: Also in Chapter 4


GO BACK TO TOP 


MEDICAL DEVICE ELECTROMAGNETIC INTERFERENCE - ANSI ISSUES
Daniel D. Hoolihan
Professional Program Proceedings: Electronics Industries Forum of New England
May 1997
p 123 - 130
Full Version of Article Reprinted With Permission From Professional Program Proceedings: Electronics Industries Forum of New England. Copyright © 1997 IEEE.

Abstract: This paper focuses on the current standards for medical device electromagnetic interference. It provides information on the American National Standards Institute (ANSI) and the ANSI Accredited Standards Committee (ASC) C63, and their roles in developing standards and guides of the EMC testing for various medical devices. It also discusses the draft version of the C63.18 document entitled "Recommended Practice for an On-Site, Ad-Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio Frequency Transmitters." This ad-hoc method can be utilized as a guide to healthcare facilities in instituting policies to assure separation of wireless phones from susceptible devices.

Subjects: History; ANSI; C63 Committee; Subcommittees of C63; Subcommittee 8-Medical Device Test Method; Working Group on Guide for On-Site Testing; Working Group on EMC of Patient Connected Medical Devices; Working Group on Interference between Wireless Phones and Hearing Aids


GO BACK TO TOP 


MEDICAL DEVICE REGULATORY REQUIREMENTS FOR ELECTROMAGNETIC COMPATIBILITY
Jonathan S. Kahan
Medical Device & Diagnostic Industry
September 1995
p 86 - 92
Full Version Of Article Reprinted With Permission From Medical Device and Diagnostic Industry. Copyright © 1995 Canon Communications LLC. 

Abstract: Electromagnetic compatibility has emerged as a key focus area for the Food and Drug Administration (FDA). In light of the growing concerns on the effects of electromagnetic interference on electronic medical equipment, the FDA has commenced several new initiatives to tackle the problem. Over the last few years, the severity of the EMI problem became apparent to the FDA as it reviewed problems involving three high-profile product types: powered wheelchairs, apnea monitors, and cardiac pacemakers. The FDA appears to be working with the industry and the industrial standards to develop regulations with the objective to ensure that EMI issues are addressed before the products are cleared to be marketed.

Subjects: Defining the Problem; FDA Takes Note; The Regulatory Response; EMC and Pre-market Submissions; The Question of Consistency


GO BACK TO TOP 


NEW FDA REGULATION ON REPORTS OF CORRECTIONS AND REMOVALS
Jonathan S. Kahan
Medical Device & Diagnostic Industry 
v 19 n 9 September 1997
p 96 - 102
Full Version Of Article Reprinted With Permission From Medical Device and Diagnostic Industry. Copyright © 1997 Canon Communications LLC.

Abstract: The Federal Drug Administration (FDA) implemented its final rule on the reports of corrections and removals provision of the Safe Medical Devices Act of 1990 (SMDA) in May 1997. It requires device manufacturers to draft new standard operating procedures and to implement employee training in the new procedures. Furthermore, the redefinition of the risk-to-health standard has significantly reduced the potential burden caused by the new regulation. If manufacturers understand the new requirements and train their personnel appropriately, the requirements will not be burdensome and will be easier to be implemented.

Subjects: Biomedical Equipment; Standards; Laws and Legislation; Health Risks


GO BACK TO TOP 


OBTAINING FDA CLEARANCE FOR MEDICAL DEVICES
Glen Dash
Compliance Engineering
January/February 1997
p 89, 90, 92, 94 - 96, 98 - 100
Full Version Of Article Reprinted With Permission From Compliance Engineering. Copyright © 1997 Compliance Engineering.

Abstract: The U.S. regulatory scheme for medical devices involves a classification scheme to identify such devices. Each medical device is assigned to one of three classifications depending on the degree of risk it poses. The least risky, designated Class I devices are subject only to general controls. The riskier devices assigned to Class II are subject to special controls involving performance standards and finally the Class III is reserved for the riskiest of devices which are determined on a case-by-case basis. A majority of the medical devices fall into Class I or Class II. This article looks at the steps involved in obtaining clearance for marketing the medical devices.

Subjects: Marketing Clearance: A Matter of Substantial Equivalence; Must I File for Clearance; What Your Submission Should Contain; What the Agency Does With Your Submission; Premarket Approvals; GMP and MDR


GO BACK TO TOP 


PROTECTING DEVICES FROM RADIO-FREQUENCY TRANSMITTERS
Dan Hoolihan
Medical Device and Diagnostic Industry
v 20 n 4 April 1998
p 58 - 60
Full Version Of Article Reprinted With Permission From Medical Device and Diagnostic Industry. Copyright © 1998 Canon Communications LLC. 

Abstract: This paper describes two guidelines that must be met by medical device manufacturers to withstand EMC checks. They are the ANSI C63.18, "Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters," and AAMI Technical Information Report (TIR), "Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers-Part 1: Radiated Radio-Frequency Electromagnetic Energy." It also provides details on the ordering of these guidelines.

Subjects: Assessing Immunity; Managing the EMC Environment


GO BACK TO TOP 


REGISTRATION, LISTING, AND INVESTIGATION OF MEDICAL DEVICES
Glen Dash
Compliance Engineering Nov/Dec 1996
p 43 - 52
Full Version Of Article Reprinted With Permission From Compliance Engineering. Copyright © 1996 Compliance Engineering.

Abstract: This paper describes in detail the registration and the listing of medical devices in the United States required to register with the FDA. The purpose of listing and registration is to keep track of all establishments involved in the manufacture and distribution of medical devices. For some medical devices, clinical data needs to be submitted to the FDA to obtain marketing clearance. This means that the device will have to be used to treat patients or diagnose disease for a limited test time. For this need, the "investigational device exemption (IDE)" has been written to allow manufacturers to conduct clinical trials with the conditions that the experimental subjects must be protected from unreasonable risk and the data from the trials must be useful.

Subjects: Biomedical Equipment; Standards; Laws and Legislation; Electronic Medical Equipment; Electronic Equipment Manufacture; Electronic Equipment Testing; Inspection; Quality Control; Specifications; Quality Assurance


GO BACK TO TOP 

2.4.2 EMC Guidelines in Europe 


ELECTRONICS CHALLENGE A GROWING EMC INDUSTRY
Paul OShea
EE-Evaluation Engineering
March 1998
p 53 - 71
Full Version Of Article Reprinted With Permission From EE - Evaluation Engineering. Copyright © 1998 Nelson Publishing, Inc.

Abstract: The ever expanding market growth of electronic devices has provided a big boost to the EMC industry. The stringent requirements of the European Union has influenced the EMC market. After the introduction of the EU directive, more and more organizations are feeling the need for rigorous EMC testing. Design procedures need to be improved to prevent interference of devices from unwanted signals. Proper equipment, filtering, and shielding would also ensure that the product meets the immunity and emission standard.

Subjects: EMC Products


GO BACK TO TOP 


EMI CONTROL: PULLING THE PLUG ON A GLOBAL PROBLEM
Michael. J. Major
Medical Device & Diagnostic Industry
v 19 n 2 February 1997
p 60 - 64
Full Version Of Article Reprinted With Permission From Medical Device and Diagnostic Industry. Copyright © 1997 Canon Communications LLC.

Abstract: In 1994, 9.2 billion dollars worth of medical equipment was exported from the United States and most of these products went to Europe. By the year 2000, exports from the U.S. are expected to reach $18 billion. However, the U.S. medical device manufacturers have a major obstacle in planning for EMI control due to the lack of clear-cut, global standards. This paper deals with the ambiguity of FDA and strict European Union electromagnetic interference requirements. It discusses how the U.S. manufacturers should approach the problem of EMI control and prepare for the local and the European market.

Subjects: FDA and EMI; U.S. Industry and EMI; Dealing with Ambiguity


GO BACK TO TOP 


EMI/RFI TEST EQUIPMENT FOCUSES ON MEDICAL DEVICE DIRECTIVE
Paul OShea
EE-Evaluation Engineering
October 1997
p 63 - 72
Full Version Of Article Reprinted With Permission From EE - Evaluation Engineering. Copyright © 1997 Nelson Publishing, Inc.

Abstract: The European Unions (EU) Medical Device Directive (MDD) outlines a procedure that medical-device manufacturers need to follow in order to obtain compliance approval to sell their products in the European Common Market. The MDD went into effect on Jan. 1, 1996, but it went through a transition period until June 1998. It divides products into four classes and for most classes, the directive requires an EU-notified body to approve the product development process. These directives are definitely forcing equipment manufacturers to take a second look at aspects related to the EMC and the electrical safety of the products. This paper also provides descriptions for a few EMI/RFI test equipment.

Subjects: Recommendations


GO BACK TO TOP 


EU REGULATION OF MEDICAL DEVICES: ARE YOU READY TO COMPLY?
Glen Dash
Compliance Engineering
July/August 1997
p 89, 90, 93, 96, 97
Full Version Of Article Reprinted With Permission From Compliance Engineering. Copyright © 1997 Compliance Engineering. 

Abstract: The European Medical Device market is expected to exceed twenty-five billion dollars per year. More than forty percent of European imports in medical devices is from the United States. However, the regulations in Europe vary a lot from the FDA requirements in the United States. This article discusses the differences between the two and the steps that need to be taken by the manufacturers take comply with the EU regulation.

Subjects: What is a Medical Device; Meeting the Directives Essential Requirements; Marketing the Medical Device in the EU


GO BACK TO TOP 


EUROPEAN MEDICAL DEVICE EMC SPECIFICATIONS
Randy Anderson and Michael Petsinger
IEEE International Symposium on Electromagnetic Compatibility 
1996
p 31 - 33
Full Version Of Article Reprinted With Permission From IEEE. Copyright © 1996 IEEE.

Abstract: The medical EMC Directive has been mandatory in the European Union since January 1, 1996. Over the past 3 years, changes from the first edition of the EN 601-1-2 have been extensive. The author reviews the current requirements and provides examples of experiences related to immunity testing. Issues associated with compliance are discussed and an insight on the development of a revision to the EMC standard for medical devices is presented.

Subjects: Electronic Medical Equipment; Electromagnetic Compatibility; Specifications; Laws and Legislation; Marketing; Standards; Performance; Electric Equipment; Evaluation


GO BACK TO TOP 


PRACTICAL PROCESS TO ENTER THE EUROPEAN SINGLE MARKET REGARDING THE EMC DIRECTIVE
Werner Hirschi and Hubert Sauvain
EMC Fribourg SA, CH-1728 Rossens, Switzerland
Full Version Of Article Not Available - Permission Pending.

Abstract: Uniform legislation and standards are needed to allow free circulation of goods within the European single market. Hence, the council of ministers of the European Communities have issued a series of technical harmonization directives during the last few years. This paper presents several devices for which EMC-Directive prescribes a conformity evaluation based on the modules B and H of the EU-Directive: Medical products belonging to the classifications IIa, IIb and III; radio-communication transmitting apparatus. The general EMC-aspects of telecommunications are examined according to the module A. The requirements which have to be fulfilled are those of the EMC-Directive.

Subjects: Electromagnetic Compatibility; Standards; Telecommunication Equipment; Biomedical Equipment; Electric Equipment; Digital Communication Systems; Mechanisms; Product Design


GO BACK TO TOP 


THE EMC DIRECTIVE: A YEAR LATER
Mike Violette
EE-Evaluation Engineering
January 1997
p 56 - 63
Full Version Of Article Reprinted With Permission From EE - Evaluation Engineering. Copyright © 1997 Nelson Publishing, Inc.

Abstract: This article describes the growth and impact of the EMC Directive one year after its implementation, taking into account the types of problem that arose during the implementation as well as the effects of the directive on test labs. It also discusses the development of EMC requirements the United States and the rest of the world.

Subjects: Lessons Learned; The Impact on Test Labs; Global Harmonization; More Directives and Standards


GO BACK TO TOP 

 

 

   
Copyright © 2010 The Center for Study of Wireless Electromagnetic Compatibility, University of Oklahoma. All Rights Reserved.