Is IEC 62353 mandatory

Short answer: no. IEC 62353 does not apply to manufacturers and cannot be referred to in medical device regulation. IEC 62354 is a guide only, a technical report, and again cannot be referred to in regulation.

Is IEC 60601 mandatory?

IEC 60601-1 is continually reviewed, and standards may be added or changed through amendments. It is considered mandatory for most markets, including the EU, the US, and Canada to show evidence of safety and performance.

What is the difference between IEC 60601 and IEC 62353?

Using IEC 60601-1 repeatedly can shorten the life of the medical device (Tests like the 25A PE resistance and/or 110% mains on applied parts testing). Choosing IEC 62353 will shorten the amount of testing while providing the minimum accepted electrical safety tests.

What IEC 62353?

As its full name implies, IEC 62353 Medical Electrical Equipment – recurrent test and test after repair of ME equipment, defines the requirements for electrical safety testing of medical electrical (ME) equipment and systems during routine intervals.

Is 60601 required by FDA?

The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.

What is the latest edition of IEC 60601 1?

IEC 60601-1 (Edition 3.2) is the newest published general standard with around 1500 single specific requirements.

What is the IEC 60601 1 standard?

IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment.

What is a single fault condition?

A Single Fault Condition is a situation in where one means for protection against a hazard is defective.

What is the maximum leakage current allowed in a medical device?

The widely accepted limit for touch current — the term newer standards use for leakage currents from the equipment case or enclosure of patient care medical equipment — is 500 μA.

What is medical device essential performance?

Definition: Essential performance “Performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk.”

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How do you define essential design outputs?

5. Verify that the design outputs that are essential for the proper functioning of the device were identified. Design outputs are the work products or deliverables of a design stage. Examples include, diagrams, drawings, specifications and procedures. The outputs from one stage may become inputs to the next stage.

What are IEC standards?

The International Electrotechnical Commission (IEC) authors international standards for all electrical, electronic and related technologies. This standards collection addresses product development, performance, compatibility and related topics in order to ensure product compatibility and environmental safety.

What are particular standards?

Particular standards (numbered 60601-2-X) define the requirements for specific products or specific measurements built into products, e.g. MR scanners (IEC 60601-2-33) or Electroencephalograms (IEC 60601-2-26). Collaterals and Particulars may have their own revisions which are different from the General Standard.

What is medical electrical equipment?

Medical electrical equipment is defined in the standard as electrical equipment, which: has an applied part – the part of the medical electrical equipment that, in normal use, necessarily comes into physical contact with the patient for the medical electrical equipment or system to perform its function.

What is IEC medical device?

IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. … It is assumed that public health authorities in many countries recognise IEC 60601-1 (Edition 3.2) as a pre-requisite for the commercialisation of electrical medical equipment.

How can leakage current be prevented?

The best ways to prevent leakage current are to always use shielded cables on motor installations and to make sure that these cables are grounded at both ends. Also, check cables and insulation for damage and replace ones that are broken or damaged.

How do you check for current leakage?

The current flowing in the ground conductor is measured by connecting the meter in series with the grounding connection of the device concerned. Leakage current clamp meter is the most popular device used to measure leakage current.

What is NC and SFC?

NC = Normal Conditions SFC : Single Fault Conditions.

What is normal and single fault conditions?

6.1 Normal condition and single fault conditions A basic principle behind the philosophy of electrical safety is that in the event of a single abnormal external condition arising or of the failure of a single means of protection against a hazard, no safety hazard should arise.

What is the maximum earth leakage current?

It’s important that you also know the current Pass Marks. Heating appliances should have a current that should be less than 0.75 milliamps per Kilowatt up to a max of 5 milliamps. Portable/handheld appliances have to have earth leakage current of less than 0.75mA to be considered safe.

What is an essential performance requirement?

Essential performance is defined as “performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable risk. … But, as required by ISO 14971, unacceptable risk is by definition, well, not acceptable.

How do you determine essential performance?

The risk acceptability can be evaluated by estimating the probability of harm and the severity of that harm. Any device function that fails and results in harm due to a hazardous situation can be considered an essential performance of that device.

What is the purpose of output design?

Objectives of Output Design To deliver the appropriate quantity of output. To form the output in appropriate format and direct it to the right person. To make the output available on time for making good decisions.

What is the difference between design input and design output?

Design inputs form the foundation of the device and are a key factor in whether or not you produce something that is safe and effective. Your design outputs are there to describe the actual device and should include the “recipe” or any documentation that goes into manufacturing your device.

What inputs are required for process design?

In the design process, your inputs are your generally your customers needs/wants/etc. These are the things (features, performance, reliability, quality, etc) that your customers find valuable and thus are willing to pay for.

Are IEC standards mandatory?

IEC International Standards are always used by technical experts; they are always voluntary and based on the international consensus of experts from many countries. … International standards are also often adopted by countries or regions to become national or regional standards.

What is the difference between ANSI and IEC?

ANSI is a design-based standard, while IEC tends to be a performance-based standard. … Electrical testing and ratings between IEC and ANSI are not necessarily the same or equivalent. IEC equipment may not pass the equivalent ANSI test, and vice versa, due to these differences.

Are IEC and EN standards the same?

IEC standards are international. EN standards are european. EN means European Norm. EN IEC is the european implementation of the IEC standard.

What do the new right believe about education?

According to the New Right’s beliefs, the role of education is to instil drive, initiative and enterprise. The New Right believe this will come from competition between schools and colleges, motivating teachers to improve standards and providing parents and students with a choice of schools and colleges.

What are universalistic values?

Universalistic values – rules and values that apply equally to all members of society, regardless of who they are. The division of labour – division of a workforce into smaller, specialized roles.

What are the two main purposes of education according to Durkheim?

Functionalist sociologist Emile Durkheim saw Education as performing two major functions in advanced industrial societies – transmitting the shared values of society and simultaneously teaching the specialised skills for an economy based on a specialised division of labour.