ISO 14698 or EN 17141

STERILIZATION CENTRAL
ISO 14698 or EN 17141: Is There a Choice for

Cleanroom Compliance?
In August 2020, the European Committee tion on surfaces and in liquids. The Gordon Ely is a senior project
for Standardization (CEN) published EN collaborations of members of WG2 resulted manager at LexaMed LLC and the
17141,1 with the new standard superseding in the development of the ISO 14698 series. chairperson of ISO/TC 209. Email:
EN 14698-1:20032 and ISO 14698-2:2003.3 The 14698 series includes ISO 14698-1, [email protected]
This process has caused some confusion as Cleanrooms and associated controlled environ-
to which standard medical device manufac- ments—Biocontamination control—Part 1:
turers should follow in their efforts to control General principles and methods, and ISO
microorganisms in cleanrooms and con- 14698-2, Cleanrooms and associated controlled
trolled environments. environments—Biocontamination control—
This article will attempt to resolve the Part 2: Evaluation and interpretation of
perplexity that this new standard has caused biocontamination data.
and describe what will happen moving • Part 1 describes the principles and basic
forward, though it will not seek to provide a methodology for a formal system to
thorough comparison between the standards. assess and control biocontamination in
cleanrooms. The formal system is the
Cleanroom Compliance Standards: means to identify potential hazards,
Historical Perspective determine the likelihood of occurrence,
Nearly 30 years ago, the International designate zones of risk, establish
Organization for Standardization (ISO) corrective and preventive actions, and
created technical committee (TC) 209 provide proper documentation. This was
(Cleanrooms and associated controlled an early attempt to set in place what is
environments). The mission of ISO/TC 209 more recently emphasized and added to
was (and still is) to develop international standards about risk assessment and
standards for cleanrooms and associated management. Part 1 also provides
controlled environments. These standards guidance (through the annexes) on
provide requirements and guidance on airborne biocontamination; validation of
normalizing facilities and operations for air samplers; measurement of biocon-
industries across the world that utilize these tamination on surfaces, textiles, laundry,
special manufacturing environments with and garments; and provision of training
the goal of minimizing various types of to personnel.
contamination. As stated on the ISO website, • Part 2 provides guidance on the evalua-
the scope of ISO/TC 209 is “Standardization tion and interpretation of
for cleanrooms and associated controlled biocontamination data. Sampling
environments for controlling cleanliness, as techniques, time factors, culturing
well as other attributes and characteristics, techniques, and analysis methods are
relating to facilities, sustainability, equip- items of discussion for monitoring (both
ment, processes and operations.”4 for validation and routine).
The first working group (WG) formed for A key point of both 14698-1 and -2 is that
the TC focused on the classification of no limits were established regarding
cleanroom environments based on airborne microbial counts. It was a sticking item
(nonviable) particle concentrations and during the meetings, with some countries
initiated the standards that became the start wanting hard limits and others debating that
of the ISO 14644 series. WG2 focused on these limits should not be included because
“viables” (i.e., microorganisms in cleanroom limits would be too strict for some indus-
environments and their control). This tries and too high for others. The argument
biocontamination control covers not only for limits based on risk won out, and the
airborne contamination but also contamina- subject of alert and action limits, as well as
Biomedical Instrumentation & Technology 2023 www.aami.org/bit 15

target levels, was in the approved versions of Addressing Uncertainty: Which

these documents. Standard to Follow?
Discussions on revising the 14698 series With both standards (ISO 14698 series and
have occurred since their approval in 2003. EN 17141) currently approved and effective,
Systematic ballots were sent to the voting confusion and uncertainty seem to have
member countries, but the series was resulted. What does this mean for medical
reapproved each time. In the mid-2010s, an device manufacturers around the world?
effort was made to reorganize WG2 and Which standard is to be used or followed, and
commence a serious effort on the revision how do companies remain compliant? What
process. This was quickly shelved due to affect does Brexit have, even though the UK
inadequate participation from voting mem- voted with CEN to supersede 14698-1 and -2?
bers in this WG. EN 17141:2020 is the valid biocontamina-
Some voting members of WG2 from tion control standard for Europe. This
countries in Europe truly believed that the change affects only Europe, specifically those
14698 series had limited application and that countries that participate with CEN. ISO
changes were needed. As a result, in 2016, 14698-1 and -2 are the biocontamination
CEN, through TC CEN/TC 243/WG5, control standards for the rest of the world,
worked on revising and updating the CEN where they have been adopted. (Note: This
versions of 14698. The result was the new EN ISO 14698 series was never adopted as
17141 standard, Cleanrooms and associated standards in the United States by the
controlled environments—Biocontamination American National Standards Institute and
control. Upon completion, the CEN member they are not considered consensus standards
countries, which included the United by the Food and Drug Administration.)
Kingdom, voted unanimously to withdraw CEN/TC 243 has proposed 17141 for
the 14698 series as approved CEN standards, inclusion in the ISO 14644 family of stand-
replacing them with 17141. ards, in order to harmonize the approach to
biocontamination control in air and on
EN 17141: Adding Substance to surfaces with that of particles and other
Previous Offerings contaminants. Within ISO/TC 209, a ballot
EN 17141 is a refinement of the 14698 series, inquiry was done in 2020 to gain input on
combining the series into one document the 14698 series. Most members agreed that
and updating the guidance to be more in it was time to start the revision process. ISO/
line with current ideas of risk assessment TC 209, during its plenary meetings late in
and management. The standard adds 2020, agreed to open WG2 and reorganize it
substance to the general ideas of establish- as steps to begin the revision process. It was
ing microbiological control and agreed that 17141 would be the basis for the
demonstration of that control. It also revision process, or in other words, it would
includes a section on microbiological be used as a starting point, then built upon
measurement methods. Of note, the WG by the WG2 members. It will not be wholly
made a decision not to address the biocon- submitted and accepted as a replacement for
tamination control of liquids, which was the 14698 series, as some had originally
included in the scope of the 14698 series. hoped. This revision process will take 18 to
Another highlight of 17141 is that some of 36 months, at the end of which will be a new
the annexes provide guidance on applying 14698 standard—along with the expectation
the standard to various industries (pharma- that CEN will adopt it and withdraw 17141.
ceutical, biopharmaceutical, medical device, In the meantime, both standards are
hospital/healthcare, and food)—informa- effective. For manufacturers that market
tion that was not described in the 14698 product in both Europe and the rest of the
series. Other annexes address the validation world, both standards will apply. If market-
of sampling methods and explain the use of ing only in Europe, manufacturers should be
rapid microbiological methods, which are following 17141. Even though Brexit has
much more common now than they were happened, trade agreements and regulations
in 2003. remain in place, allowing for a transition

over time rather than immediately. No 2. ISO 14698-1:2003. Cleanrooms and associated
known effort has occurred to revert back to controlled environments—Biocontamination
the 14698 series, and it appears that the UK control—Part 1: General principles and methods.
will continue with 17141 despite Brexit. Geneva, Switzerland: International Organization
for Standardization.
Conclusion 3. ISO 14698-2:2003. Cleanrooms and associated con-
Each medical device company should trolled environments—Biocontamination control—
compare the ISO 14698 series and EN 17141 Part 2: Evaluation and interpretation of biocontam-
and identify potential gaps in compliance, in ination data. Geneva, Switzerland: International
order to avoid putting the company at risk. Organization for Standardization.
In the ever-changing world of regulations,
4. International Organization for Standardization.
this process is normal. It is anticipated that
ISO/TC 209: Cleanrooms and associated controlled
the possibility of having to conform to two
environments. www.iso.org/committee/54874.
standards will last a short time and that
html. Accessed Feb. 8, 2023.
biocontamination control within cleanrooms
and controlled environments will be harmo-
nized under a single standard from ISO.
References
1. EN 17141:2020. Cleanrooms and associated con-
trolled environments—Biocontamination control.
Brussels, Belgium: European Committee for
Standardization.

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STERILIZATION CENTRAL

ISO 14698 or EN 17141: Is There a Choice for

Biomedical Instrumentation & Technology 2023 www.aami.org/bit 15

target levels, was in the approved versions of Addressing Uncertainty: Which

Biomedical Instrumentation & Technology 2023 www.aami.org/bit 16

Biomedical Instrumentation & Technology 2023 www.aami.org/bit 17

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