FORM 1:
PROPOSAL FOR A NEW FIELD OF TECHNICAL ACTIVITY
Circulation date2020-07-04

Reference number: Enter Number(to be given by ISO Central Secretariat)

Closing date for voting
2020-09-26
Proposer
SAC

ISO/TS/P 290

A proposal for a new field of technical activity shall be submitted to the ISO Central Secretariat,
which will assign it a reference number and process the proposal in accordance with the ISO/IEC
Directives Part 1, Clause 1.5. The proposer may be a member body of ISO, a technical committee,
subcommittee or project committee, the Technical Management Board or a General Assemblycommittee, the Secretary-General, a body responsible for managing a certification system
operating under the auspices of ISO, or another international organization with national bodymembership. Guidelines for proposing and justifying a new field of technical activity are given in
the ISO/IEC Directives Part 1, Annex C.

Proposal (to be completed by the proposer)
Title of the proposed new committee (The title shall indicate clearly yet concisely the new
field of technical activity which the proposal is intended to cover).
Laboratory Design

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Scope statement of the proposed new committee (The scope shall precisely define thelimits of the field of activity. Scopes shall not repeat general aims and principles
governing the work of the organization but shall indicate the specific area concerned).
Standardization in the field of laboratory design including site selection, design of internal layout of
space and services with the objective to provide functional, safe, energy efficient and sustainable
laboratories taking into account environmental impact, the practical division of experimental andsupport areas and layouts plus model selection of laboratory furniture.
It includes standardization of apparatus and devices for personal safety aspects that are an integral
part of the laboratory. Design of devices and apparatus for experiment purposes covered by ISO/TC
48 as well as design of measuring instruments are excluded from the scope.
Excluded:
•
•
•
•
•

ISO/TC 48 (laboratory equipment);
ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems);
CASCO;
IEC/TC 66 (Safety of measuring, control and laboratory equipment);
ISO/TC 209 (Clean rooms).

Once the new TC is established, liaisons with other relevant ISO technical committees will beestablished, including:
•
•
•
•
•
•

ISO/TC 48 (laboratory equipment);
ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems);
CASCO;
ISO/TC 136 (Furniture);
ISO TC 307 (Blockchain and distributed ledger technologies);
ISO/TC 159 (Ergonomics);

as well as relevant IEC technical committees:•
IEC/TC 64 (Electrical installations and protection against electric shock);•
IEC/TC 81 (Lightning protection);•
IEC/TC 85 (Measuring equipment for electrical and electromagnetic quantities);•
IEC/TC 45 (Nuclear instrumentation);•
IEC/TC 62 (Electrical equipment in medical practice);•
IEC/TC 65 (Industrial-process measurement, control and automation);•
IEC/TC 76 (Optical radiation safety and laser equipment);•
IEC/TC 104 (Environmental conditions, classification and methods of test);•
and ISO/IEC JTC 1 (Information technology).
The proposed TC will not pursue subjects within the scope of other TCs including but not limited to
ISO and IEC TCs listed above.
Note: the proposed TC will help laboratory design industry to address a wide range of global issues.
Outbreaks of zoonotic disease like Avian Influenza (H5N1), Middle East Respiratory Syndrome(MERS), Ebola virus, Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory
Syndrome (MERS) and Coronavirus (COVID-19) has highlighted the worldwide lack of adequate
laboratory capacity, especially in low-resource environments. This proposal should address thissituation, early during the design stage, by providing a standardised approach on laboratory
function, health and safety, energy efficiency, environmental impact and regulatory complianceissues.

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Form 1: Proposal for a new field of technical activity
Page 3The proposer has checked whether the proposed scope of the new committee overlaps
with the scope of any existing ISO committee
If an overlap or the potential for overlap is identified, the affected committee has been
informed and consultation has taken place between proposer and committee on
i. modification/restriction of the scope of the proposal to eliminate the overlap,
ii. potential modification/restriction of the scope of the existing committee toeliminate the overlap.
If agreement with the existing committee has not been reached, arguments arepresented in this proposal (under question 7) as to why it should be approved.

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Proposed initial programme of work. (The proposed programme of work shallcorrespond to and clearly reflect the aims of the standardization activities and shall,
therefore, show the relationship between the subject proposed. Each item on the
programme of work shall be defined by both the subject aspect(s) to be standardized(for products, for example, the items would be the types of products, characteristics,
other requirements, data to be supplied, test methods, etc.). Supplementary justification
may be combined with particular items in the programme of work. The proposed
programme of work shall also suggest priorities and target dates.)
The new TC will stipulate technical design requirements for a diverse range of laboratories withdifferent functions and responsibilities. It will include, but not limited to:
1. site selection and planning;
2. layouts and selection of model furniture (e.g. workbenches, fume hoods, safety showers,
biological safety cabinets, etc);
3. electrical, water and gas supply systems, drainage, fire prevention, HVAC, auto-control anddecoration;
4. laboratories featuring bio-safety, constant temperature and humidity, and other special
laboratories;
5. laboratory safety, staff health and wellness, environmental protection, and energy saving;
6. Smart laboratory (Use of big data, cloud computing, Internet of things, blockchain, artificial
intelligence and other digital technologies to monitor and control the environmental conditionsof the laboratory, so as to have better performance operation of facilities, energy
conservation, environmental protection and personnel health).
Initial Work Programme over 3 to 5 years will develop and prepare common design requirements fordifferent types of laboratories and submit international standards (IS): “General Specification ofTechnical Requirements for Laboratory Design” and “Technical Requirements for Smart Laboratory
Design”.
The programme will:a. build the framework for drafting “General Specification of Technical Requirements forLaboratory Design”;
b. classify laboratory types and define terminology;c.

clarify the principles of laboratory design requirements for various disciplines andacceptance requirements of laboratory functions;d. clarify the technical design requirements for laboratories utilizing digital technologies forenvironmental control;e. prepare IS “General Specification of Technical Requirements for Laboratory Design”;
f.

prepare IS “Technical Requirements for Smart Laboratory Design”.

Based on categorization of laboratory types and framework of the “Technical Requirements ofLaboratory Design”, future Work Programme over a period of 3 to 5 years will develop the technicalrequirements for design of various types of laboratories, e.g. vaccines development and manufacture,pharmaceutical, food and agricultural product, petrochemical, police etc.

Indication(s) of the preferred type or types of deliverable(s) to be produced under the
proposal (This may be combined with the "Proposed initial programme of work" if moreconvenient).
Combined with “Proposed initial programme of work”.

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Form 1: Proposal for a new field of technical activity
Page 5A listing of relevant existing documents at the international, regional and national levels.
(Any known relevant document (such as standards and regulations) shall be listed,regardless of their source and should be accompanied by an indication of theirsignificance.)
1. There are no recognised international standards on any major aspect of Laboratory Design. Many
countries have formulated national building, safety and laboratory design regulations andguidelines but no global systematic standards on laboratory design that can be widely applied
across the world have been developed.
2. China has released some national standards related to laboratory design and construction.
3. Standards Australia/New Zealand has issued a Laboratory design and construction Standard(AS/NZS 2982:2010).
4. Standards and guidelines of relevance to the work of the proposed TC from China and othercountries are listed in Annex 1.
Country/
Organization
Australia/New
Zealand
CanadaStandard headlines
AS/NZS 2982:2010 Laboratory design and construction

China

Canadian Biosafety Standard (https://www.canada.ca/en/publichealth/services/canadianbiosafety-standardsguidelines/second-edition.html) - regulatory standard for thedesign and construction of biosafety/biosecurity laboratories
GB50346 Biosafety Laboratory Building Specification

China

GB19489 Laboratory - General Requirements for Biosafety

China

GB/T27476.1 Safety of Testing Laboratory

China

JGJ 91-93 Design code for scientific experiment buildings.

China

GB/T 32146.1-2015 Technical requirements of design andconstruction for inspection and testing laboratory- Part 1:general
specification
GB/T 32146.2-2015 Technical requirements of design andconstruction for inspection and testing laboratory- Part 2:Electricallaboratory
GB/T 32146.3-2015 Technical requirements of design andconstruction for inspection and testing laboratory- Part 3:Foodlaboratory

China
China

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Laboratory
category
Generallaboratory
specializedlaboratory
Biosafety
laboratory
Biosafety
laboratory
Biosafety
laboratory
TestingLaboratory
Scientificresearchlaboratory
Testinglaboratory
Testinglaboratory
Testinglaboratory／

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A statement from the proposer as to how the proposed work may relate to or impact on
existing work, especially existing ISO and IEC deliverables. (The proposer should explain
how the work differs from apparently similar work, or explain how duplication and conflict
will be minimized. If seemingly similar or related work is already in the scope of othercommittees of the organization or in other organizations, the proposed scope shalldistinguish between the proposed work and the other work. The proposer shall indicate
whether his or her proposal could be dealt with by widening the scope of an existingcommittee or by establishing a new committee.)
The mission of the proposed TC is to develop a series of standards for design of different types oflaboratories, and provide technical guidance for efficient laboratory function including the usage ofdigital technologies to better monitor and control environmental conditions and impact. At present,
there is no ISO TC or SC covering laboratory design. ISO17025, ISO 15189 and ISO TC 48 mention
laboratories but do not cover laboratory design. ISO 17025 and ISO 15189 focus on capacity andquality management requirements of the laboratory. ISO TC48 is limited to standards for laboratory
equipment and glassware and has no conflict with the standards to be drafted by the proposed newTC.
The scope of ISO TC209 is standardization for cleanrooms and associated controlled environments forcontrolling cleanliness, as well as other attributes and characteristics, relating to facilities,
sustainability, equipment, processes and operations. Most of laboratories do not include clean rooms;
however for laboratories that have clean rooms, the standards developed by the new TC will have toconform or refer to standards from ISO TC 209.
IEC/TC 66 addresses safety of measuring, control and laboratory equipment. The standards
developed by the new TC will conform or refer to standards from IEC TC 66 for the electrical safety oflaboratory equipment.

A listing of relevant countries where the subject of the proposal is important to theirnational commercial interests.
Laboratories are a key component supporting both private and public sectors in a sustainableeconomy, including healthcare (especially medical diagnostic, vaccines development/manufacture)
and agriculture. The outcomes and outputs of the proposed TC should be of interest to a great
number of countries, including those in developed and emerging economies. It would enablecountries to address a wide range of global issues and reach the UN Sustainable Development Goals(SDGs) for health, eradication of hunger and poverty, climate change and economic development.

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Form 1: Proposal for a new field of technical activity
Page 7A listing of relevant external international organizations or internal parties (other ISO
and/or IEC committees) to be engaged as liaisons in the development of thedeliverable(s). (In order to avoid conflict with, or duplication of efforts of, other bodies, it
is important to indicate all points of possible conflict or overlap. The result of any
communication with other interested bodies shall also be included.)
1.Internal parties: these are all committees named above.
a. ISO committees: ISO/TC 48, ISO/TC 212, CASCO, ISO/TC 209; ISO/TC 136, ISO/TC
307 and ISO/TC 159.
b.

IEC committees: IEC/TC 45, IEC/TC 62, IEC/TC 64, IEC/TC 65, IEC/TC66, IEC/TC 81,
IEC/TC 76, IEC/TC85 and IEC/TC 104.

c.

ISO/IEC JTC 1.

2.External organizations:a.
Union Internationale des Laboratoires Indépendants (UILI);b.

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European Federation of National Associations of Measurement, Testing and Analytical
Laboratories (EUROLAB).

Form 1: Proposal for a new field of technical activity
Page 8A simple and concise statement identifying and describing relevant affectedstakeholder categories (including small and medium sized enterprises) and how they
will each benefit from or be impacted by the proposed deliverable(s).
The setting up of laboratory design TC and establishment of laboratory design standards will
benefit organizations and groups as follows:
1.

Laboratory owners (including governments, scientific agencies and enterprises, etc.):
Laboratory owners will understand the principles and methods of laboratory design for better
management of laboratory design, construction, acceptance and operation. The investment
budget will have a reference basis; construction cost will be better controlled; investment risk will
be lowered; project quality can be better evaluated; construction cycle will be shortened; capital
usage efficiency will be raised;

2.

Laboratory designers:
Laboratory designers will understand the principles and methods of laboratory design, and will
have standards to follow and verify by, make fewer design faults and ensure laboratory design tobe more scientific and professional; laboratory environmental facility will be improved in terms ofsafety, energy conservation, environmental friendliness, as well as impacts on human health andwell-being.

3.

Laboratory construction industry:
The proposed TC will provide a series of design standards that constructors can refer to when
preparing mutually acceptable and clearly defined performance and acceptance criteria. The
construction quality will be raised and technology advancement promoted.

4.

Laboratory users:
Laboratory users will understand the principles and methods of laboratory design; stakeholders
can communicate with each other in a more informed way and evaluate laboratories based oncommon standards, making laboratory use, operation and management more scientific andregulated. Digital control of laboratories will allow more functions and add value by utilising
emerging technologies of big data, cloud computing and internet of things, etc.

5.

Laboratory operators:
Laboratory operators will understand the principles and methods of laboratory design, which will
facilitate the maintenance of laboratories; Digital technologies will also enable remote control oflaboratory operation and facilitate reliable, convenient, efficient and reliable maintenance.

6.

Society:
The society will be able to cultivate more professional personnel in the field of laboratory design;a more sound and fair development of laboratory design and construction both home and abroad
will be facilitated; more energy-saving and environmental-friendly design will promote thesustainable development of the society; the premium laboratories will inspire the creativity of
researchers and promote the advancement and development of technologies. Digital control oflaboratories will facilitate technological progress, product quality improvement, data recognition
as well as international trade.

An expression of commitment from the proposer to provide the committee secretariat if
the proposal succeeds.
If the proposal is accepted, China is willing to undertake the work of secretariat of the new TC and will
provide all necessary resources including financial and human resources as well as facility supports.
A partnership agreement between China and France at committee level is foreseen.

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Form 1: Proposal for a new field of technical activity
Page 9Purpose and justification for the proposal. (The purpose and justification for thecreation of a new technical committee shall be made clear and the need forstandardization in this field shall be justified. Clause C.4.13.3 of Annex C of the ISO/IEC
Directives, Part 1 contains a menu of suggestions or ideas for possible documentation
to support and purpose and justification of proposals. Proposers should consider thesesuggestions, but they are not limited to them, nor are they required to comply strictlywith them. What is most important is that proposers develop and provide purpose andjustification information that is most relevant to their proposals and that makes asubstantial business case for the market relevance and the need for their proposals.
Thorough, well-developed and robust purpose and justification documentation will leadto more informed consideration of proposals and ultimately their possible success in
the ISO IEC system.)
The rationale for setting up laboratory design TC is as follows:
1. laboratories serve as the foundation for technological progress and product quality assurance andplay a pivotal role in social and economic development. Worldwide, the laboratory construction
volume is rising year by year, with trillions of USD invested into construction of new laboratories andrenovation of existent ones. However, on a global scale there is no standard on design of various
types of laboratories that project owners, designers, users and quality supervision authorities canrefer to, resulting in a number of problems in laboratory construction worldwide;
2. lack of systematic laboratory design standards is the fundamental cause of frequent occurrence oflaboratory accidents impacting laboratory safety and occupants’ health, some of which may also
seriously jeopardize public health;
3. currently there are no internationally agreed systematic standards on laboratory design andconstruction. The existing ISO laboratory quality management standards ISO/IEC 17025:2017(Section 6.3: Facilities and environmental conditions) and ISO 15189 2012 (Section 5.2
Accommodation and environmental conditions) recognizes that robust and quality outputs fromlaboratories are dependent on their facilities and environmental conditions but does not provide any
guidance on laboratory design;
4. in recent years, there is an increasing demand from Chinese market for various types oflaboratories, with hundreds billions of Chinese RMB invested each year in laboratory construction.
In the process, the standards system of laboratory design and construction in China have been
gradually established. First of all, the common characteristics of different regions and types oflaboratories were summarized as the general requirements of laboratory design and construction.
And then, the technical requirements for design and construction of different types of laboratories
were specified. Now China has not only developed laboratory design standards, but also laboratory
construction and acceptance standards, with the corresponding standards for laboratoryenvironmental facilities being established along the way. China’s laboratory design standards
system not only covers the general planning of laboratory, experiment procedure, layout, electricaland water supply, drainage, heating, ventilation and air purification, furniture, fire prevention, safety,
energy efficiency and environmental protection. During the standards compilation, experts andscholars integrated new technologies, materials and processes proven technically and economicallyeffective in practice into the standards, which has greatly improved the level of laboratory
construction in China, and provided support to the economic and social development. By setting up
the laboratory design TC, China is willing to harness its accumulated experience and work together
with other ISO member countries on the development of ISO laboratory design standard, in order tobenefit other countries around the world;

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5. it has been shown in many cases that, as a result of unhealthy laboratory of environment, theresearchers working in laboratories developed diseases such as lung cancer, leukaemia and brain
cancer. The underlying causes of these problems are the lack of laboratory design standards
addressing health and safety;
6. environmental protection, energy efficiency and emissions reduction in laboratory construction will
be given more prominence, addressing climate change issues and meeting sustainable
development goals;
7. lack of standards on Smart laboratories that integrate facilities and instrumentation has adversely
impacted the generation and utilization of quality laboratory data;
8. many national or regional standards on many aspects of laboratory design and construction exist.
Developing a consistent and internationally acceptable approach taking all these into account will
prove a challenging task. This TC will provide an overview of these existing standards, categorise
best practices and endeavour to integrate and refer to them in a globally acceptable international
standard.

The establishment of laboratory design TC will:
1. promote the development and implementation of international standards on laboratory design;
2. provide standards for the design of various types of laboratories and allow laboratory designprinciples and methods to be known on a global scale in order to avoid the occurrence ofaccidents impacting safety and health;
3. provide professional references for ensuring scientific laboratory facilities and environmental
conditions, and technical support to guarantee the data reliability of research and testinglaboratories;
4. provide technical requirements on laboratory environment conditions in order to minimize theadverse impact on the health of laboratory personnel and insure ttheir wellbeing;

5. provide technical requirements on environment protection in order to promote energy saving andemission reduction.

Signature of the proposer
SAC

Further information to assist with understanding the requirements for the items above can befound in the Directives, Part 1, Annex C.

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Form 1: Proposal for a new field of technical activity
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ANNEX 1
Planning principles / laws, standards and regulations from various
countries:
Australia / New Zealand
1. AS/NZS 2982:2010 Laboratory design and construction
2. AS/NZ 2243 Safety in Laboratories Series:
a. AS/NZ 2243.1:2005 Planning and Operational Aspects
b. AS/NZ 2243.2:2006 Chemical Aspects
c. AS/NZ 2243.3:2010 Microbiological safety and containmentd. AS/NZS 2243.4:2018 Safety in laboratories - Ionizing radiations
e. AS/NZ 2243.5:2004 Non-ionizing radiations – Electromagnetic, soundand ultrasoundf.

AS/NZ 2243.6:2010 Plant and equipment aspects

g. AS/NZ 2243.7:1991 Electrical aspects
h. AS/NZ 2243.8:2014 Fume cupboardsi.

AS/NZ 2243.9:2009 Recirculating fume cabinets

j.

AS/NZ 2243.10:2004 Storage of chemicals

Switzerland
1. Labor Law (ArG), its regulations and the guidelines
2. Law on the safety of technical equipment and devices" (STEG)
3. Regulation on the safety of technical equipment and devices" (STEV)
4. Ordinance on the protection of workers against endangerment by microorganisms" (SAMV)
5. Inclusion Ordinance (ESV) No. 814.912, Ordinance on the Handling of
Organisms in Closed Systems
6. Ordinance on the handling of organisms in the environment (release ordinance,
FrSV)
7. Radiation Protection Ordinance No. 814.554, Ordinance on the handling of
open radioactive radiation sources

Switzerland Federal Coordination Commission for Occupational Safety(EKAS)
1. EKAS - Guideline No. 1871 Chemical laboratories
2. EKAS - Guideline No. 6501 acids and alkalis
3. EKAS - Guideline No. 1825 Flammable liquids
4. EKAS Guideline No. 6508 Involvement of occupational physicians andother occupational safety specialists
5. EKAS - Guideline No. 6512 Work equipment
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6. EKAS 6807 Checklist: Maintenance of ventilation and air conditioning
systems (RLT systems)
7. SUVA - Directive "Explosion Protection - Principles, Minimum
Requirements, Zones"
8. SUVA- Fact sheet No. 33038 "Internal transport of easily combustible
liquids"
9. SUVA - Guideline no. 1864.d Guidelines for cold rooms and freezers
10. SUVA 67001 Traffic routes for persons
11. SUVA 67009 Noise at work
12. SUVA 67012 floors
13. SUVA 67013 Handling of solvents
14. SUVA 67032 Storage shelves and drawer cabinets
15. SUVA 67045 Cleaning and maintenance of buildings
16. SUVA 67054 Compressed airSUVA 67068 Gas cylinders
17. SUVA 67070 Vibrations at workSUVA 67071 Storage of easily
combustible liquids
18. SUVA 67072 Doors and gates
19. SUVA 67083 Static electricity. Explosion risks when handling flammableliquids
20. SUVA 67084 Acids and alkalis
21. SUVA 67089 Load transport by hand
22. SUVA 67091 Personal Protective Equipment
23. SUVA 67132 Explosion risks (Explosion protection document for SMEs)
24. SUVA 67142 storage and stacking
25. SUVA 67149 Dealing with microorganisms
26. SUVA 67157 Escape routes
27. SUVA 67171 Technical noise protection measures
28. SUVA 67189 Stop the tripping and falling accidents when cleaningbuildings
29. SUVA 84040 Eight vital rules for the maintenance of machinery andequipment
30. SUVA 84042 5 + 5 vital rules in dealing with electricity
31. SUVA Limits at the workplace
32. SUVA 86048 Acoustic limit and guide values
EN standards
1. EN 12128 "Biotechnology - Laboratories for research, development andanalysis - Containmentlevels of microbiological laboratories, areas ofrisk, localities and physical safety requirements".
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2. EN 14056 "Laboratory furniture - Recommendations for design andinstallation"EN 14175 "Fume cupboards " (part 1 to 7)EN 13150
Workbenches for laboratories - Dimensions, safety requirements andtest methodsEN 13792 Colour coding of taps and valves for use inlaboratories
3. EN 14470 Fire safety storage cabinets (part 1 and 2)EN 312
Particleboards - Specifications
4. EN 15154 Emergency safety showers (part 1 to 4)
5. EN ISO 14644 Cleanrooms and associated controlled environments(part 1 to 15)
France1. NF X 15-206 " Laboratory fume cupboards - Threshold for confinementtest"
2. NF X 15-211 " Laboratory equipment - Recirculatory filtration fume
cupboard - General, classification, requirements"
3. NF X 15-221 " Emergency safety showers - Permanently plumbed-inbody showers for sites other than laboratories"
Germany
1. DIN 12980 Laboratory installations - Safety cabinets and glove boxes forcytotoxic substances and other CMR drugs "China
1. GB50346 Biosafety Laboratory Building Specification
2. GB19489 Laboratory - General Requirements for Biosafety
3. GB/T27476.1 Safety of Testing Laboratory
4. JGJ 91-93 Design code for scientific experiment buildings.
5. GB/T 32146.1-2015 Technical requirements of design and construction
for inspection and testing laboratory- Part 1: general specification
6. GB/T 32146.2-2015 Technical requirements of design and construction
for inspection and testing laboratory- Part 2: Electrical laboratory
7. GB/T 32146.3-2015 Technical requirements of design and construction
for inspection and testing laboratory- Part 3: Food laboratory

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