SIST EN ISO 11979-7:2006
(Main)Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
This part of EN 13503 specifies particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
NOTE: Any other type of IOL not directly covered by EN 13503 and any IOL for which the sponsor wishes to investigate claims in addition to those defined in EN 13503 may be clinically evaluated by reference to EN 540.
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-7:2006)
Dieser Teil von ISO 11979 legt besondere Anforderungen an die klinische Prüfung von monofokalen Hinterkammer- und Vorderkammer-Intraokularlinsen, die zur Korrektur der Aphakie dienen, fest.
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO 11979-7:2006)
L'ISO 11979-7:2006 spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intraoculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie.
Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave (ISO 11979-7:2006)
Ta del standarda EN 13503 določa posebne zahteve za protokole kliničnih raziskav za monofokalne intraokularne leče v zadnjem in sprednjem prekatu za korekcijo afakije.
OPOMBA: Katera koli druga vrsta intraokularnih leč, ki ni neposredno zajeta v standardu EN 13503, in katera koli intraokularna leča, v zvezi s katero želi sponzor raziskati trditve, poleg leč iz standarda EN 13503, se lahko klinično ovrednoti s sklicevanjem na standard EN 540.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11979-7:2006
01-julij-2006
1DGRPHãþD
SIST EN 13503-7:2002
2þHVQLYVDGNL LPSODQWDWL ,QWUDRNXODUQHOHþHGHO .OLQLþQHUD]LVNDYH ,62
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-
7:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-
7:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO
11979-7:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-7:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 11979-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2006
ICS 11.040.70 Supersedes EN 13503-7:2001
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations (ISO 11979-7:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques (ISO 11979-7:2006) Klinische Prüfungen (ISO 11979-7:2006)
This European Standard was approved by CEN on 13 April 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-7:2006: E
worldwide for CEN national Members.
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EN ISO 11979-7:2006 (E)
Foreword
This document (EN ISO 11979-7:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" in collaboration with Technical Committee CEN/TC 170
"Ophthalmic optics", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by November 2006, and conflicting national
standards shall be withdrawn at the latest by November 2006.
This document supersedes EN 13503-7:2001.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 11979-7:2006 has been approved by CEN as EN ISO 11979-7:2006 without any
modifications.
2
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INTERNATIONAL ISO
STANDARD 11979-7
Second edition
2006-05-01
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques
Reference number
ISO 11979-7:2006(E)
©
ISO 2006
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ISO 11979-7:2006(E)
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ii © ISO 2006 – All rights reserved
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ISO 11979-7:2006(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Justification for a clinical investigation . 1
5 Ethical considerations. 1
6 General requirements. 2
6.1 General. 2
6.2 Additional requirements . 2
Annex A (informative) Elements of a clinical investigation . 4
Annex B (informative) Evaluation of post-operative adverse event and visual acuity rates. 13
Bibliography . 18
© ISO 2006 – All rights reserved iii
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ISO 11979-7:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11979-7 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 11979-7:2001), which has been technically
revised.
ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular lenses:
⎯ Part 1: Vocabulary
⎯ Part 2: Optical properties and test methods
⎯ Part 3: Mechanical properties and test methods
⎯ Part 4: Labelling and information
⎯ Part 5: Biocompatibility
⎯ Part 6: Shelf-life and transport stability
⎯ Part 7: Clinical investigations
⎯ Part 8: Fundamental requirements
⎯ Part 9: Multifocal intraocular lenses
⎯ Part 10: Phakic intraocular lenses
iv © ISO 2006 – All rights reserved
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INTERNATIONAL STANDARD ISO 11979-7:2006(E)
Ophthalmic implants — Intraocular lenses —
Part 7:
Clinical investigations
1 Scope
This part of ISO 11979 specifies particular requirements for clinical investigations for posterior and anterior
chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11979-1, ISO 14155-1 and
ISO 14155-2 apply.
4 Justification for a clinical investigation
The requirements given in ISO 14155-1 shall apply.
If a new model is a minor modification of a model for which the safety and performance have been established
through clinical investigation in accordance with this part of ISO 11979, no or limited clinical investigation is
needed. ISO/TR 22979 provides guidance in determining if a modification is minor.
5 Ethical considerations
For clinical investigations of medical devices for human subjects, the requirements in ISO 14155-1 shall apply.
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ISO 11979-7:2006(E)
6 General requirements
6.1 General
The general requirements for a clinical investigation given in ISO 14155-1 and the clinical investigation plan
requirements in ISO 14155-2 shall apply, with additional requirements given below.
6.2 Additional requirements
6.2.1 Design
A clinical investigation of an IOL model shall be designed in one of two ways:
a) as an uncontrolled study, in which case the results are compared to the adverse events and visual acuity
rates given in Annex B.
b) as a controlled study, with the provision that the statistical power to detect differences in the adverse
event rates and visual acuity is similar to the uncontrolled study. The control lens shall conform with
applicable parts of ISO 11979.
NOTE Annex A provides guidance for the design of a clinical investigation.
6.2.2 Variables
The following variables shall be considered:
⎯ best spectacle corrected visual acuity (BSCVA);
⎯ refraction;
⎯ intraocular pressure;
⎯ corneal status;
⎯ iritis;
⎯ IOL decentration;
⎯ IOL tilt;
⎯ IOL discoloration;
⎯ IOL opacity;
⎯ cystoid macular oedema;
⎯ hypopyon;
⎯ endophthalmitis;
⎯ pupillary block;
⎯ retinal detachment;
⎯ status of anterior and posterior capsule.
Additional variables can be studied in the clinical investigation to support specific claims.
2 © ISO 2006 – All rights reserved
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ISO 11979-7:2006(E)
6.2.3 Other considerations
To minimize the risks associated with the clinical investigation of a new IOL, subject enrolment shall occur in
stages. The subject data from each stage shall be evaluated and found acceptable by the sponsor and the
coordinating investigator prior to the continuation of the clinical investigation. Guidance on phased enrolment
is included in Annex A.
Only the first eye of each subject shall be included in the primary statistical analysis.
Any plans for fellow eye implantation shall be described in the clinical investigation plan. Bilateral implantation
shall not be implemented until initial safety and effectiveness data have been collected, evaluated and
confirmed by the sponsor and principal investigators.
The review of data from at least 50 eyes with six months of follow-up is recommended. Previous clinical
experience, i.e. results from well-documented clinical investigations, may be adequate justification to begin
bilateral implantation earlier in the study.
The duration of the clinical investigation shall be one year for all posterior chamber IOLs, and 3 years for all
anterior chamber IOLs.
The clinical investigation plan shall contain descriptions of the surgical technique, the intraoperative use of
ophthalmic viscosurgical devices, and the use of preoperative, intra-operative and post-operative medications.
Any deviation shall be recorded on the case report forms.
The clinical investigation plan shall describe how subject visits and ophthalmic adverse events in between
reporting periods will be handled in the data analyses.
All subjects in a clinical investigation shall be monitored for the duration of the investigation. The clinical
investigation shall be considered completed when all subjects that have been enrolled in the investigation,
including subjects whose IOL was removed or replaced, have reached the final reporting period.
Serious ophthalmic adverse events and all adverse device effects shall be reported using a special case
report form and forwarded to the sponsor as required. All other ophthalmic adverse events shall be reported
using the standard visit case report forms and are collected during monitoring.
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ISO 11979-7:2006(E)
Annex A
(informative)
Elements of a clinical investigation
A.1 General
The following are elements of a clinical investigation plan which can assist in collecting data for the purpose of
determining the safety and performance of IOLs.
NOTE This annex reflects the experience with clinical investigations of IOLs in the USA.
A.2 Number of subjects
The clinical investigation includes a minimum of 300 subjects when the results are compared to the safety and
performance endpoints in Annex B. In the case of a study with a concurrent control group, calculate the
number of subjects sufficient to detect differences in the safety and performance endpoints in Annex B with
similar statistical power to the study mentioned above. Any additional claims, beyond those for safety and
performance, require calculation of a sample size for that purpose.
To take into account that some subjects are lost during the course of the clinical investigation (including
deceased subjects and subjects who have the IOL explanted), enrol about:
a) 390 subjects in the one-year investigation;
b) 500 subjects in the three-year investigation.
Significantly larger numbers of subjects are not to be enrolled in order to minimize exposure to the risks of a
new IOL.
To assist in achieving a balance in the number of subjects from each investigator, each surgeon contributes a
minimum of 20 subjects, but no more than 25 % of the subjects in the investigation.
If the risk analysis determines that a limited clinical investigation is sufficient (see ISO/TR 22979), then enrol
125 subjects.
A.3 Phased enrolment
To minimize the potential risks, the clinical investigation consists of two phases as follows.
a) Phase 1:
A maximum of 100 subjects are included. After at least 50 of those have reached case report Form 4,
their data are evaluated. If the results are acceptable, the next phase can begin.
b) Phase 2:
The remainder of the subjects are included.
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ISO 11979-7:2006(E)
A.4 Reporting periods
The time frames for the reporting periods are defined below:
a) Case report Form 0: pre-operative/operative reporting;
b) Case report Form 1: post-operative reporting 1 d or 2 d post-operatively;
c) Case report Form 2: post-operative reporting 7 d to 14 d post-operatively;
d) Case report Form 3: post-operative reporting 30 d to 60 d post-operatively;
e) Case report Form 4: post-operative reporting 120 d to 180 d post-operatively;
f) Case report Form 5: post-operative reporting 330 d to 420 d post-operatively;
g) Case report Form 6: post-operative reporting 630 d to 780 d post-operatively;
h) Case report Form 7: post-operative reporting 990 d to 1 140 d post-operatively.
The minimum number of completed case report forms for each reporting period is 300.
A.5 Standardization of the clinical evaluation
Define criteria for evaluation of all studied variables. Define testing conditions for all measurements. Before
commencing the investigation instruct and train all investigators to use these, in order to obtain data that can
be combined for the purpose of statistical analysis.
A.6 Data analysis
Consider the following analyses:
a) VA stratified by age;
b) best-case VA;
c) VA stratified by adverse event;
d) VA stratified by pre-operative ocular pathology;
e) VA stratified by investigator;
f) subject-by-subject analysis of reasons why subject failed to achieve 0,5 (6/12; 20/40) VA;
g) rate of visual acuity decrease of 10 letters or more on an early treatment of diabetic retinopathy study
(EDTRS) chart (or equivalent) between a form evaluation and a later form evaluation with the cause of
the visual acuity decrease described in each case;
h) rates of cumulative adverse events stratified by age;
i) rates of persistent adverse events stratified by age;
j) adverse event stratified by investigator.
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ISO 11979-7:2006(E)
A.7 Subject accountability
The general requirement for accountability of subjects is given in ISO 14155-1. More specific guidance for
subject accountability at each of the post-operative visits in IOL clinical investigations is provided in Table A.1.
Table A.1 — Accountability by post-operative visit
Total number
Subject status
a
Enrolled Form 1 Form 2, etc. Final form
N
tot
n , n , n ,
b aa aa aa
Available for analysis , n
aa
(n /N ) % (n /N ) % (n /N ) %
aa tot aa tot aa tot
Missing subjects:
n , n , n ,
c d d d
Discontinued , n
d
(n /N ) % (n /N ) % (n /N ) %
d tot d tot d tot
Missing at scheduled visit but seen n , n , n ,
sl sl sl
d
later , n (n /N ) % (n /N ) % (n /N ) %
sl sl tot sl tot sl tot
n , n , n ,
e ns ns ns
Not seen but accounted for , n
ns
(n /N ) % (n /N ) % (n /N ) %
ns tot ns tot ns tot
n , n , n ,
f lf lf lf
Lost to follow-up , n
lf
(n /N ) % (n /N ) % (n /N ) %
lf tot lf tot lf tot
n , n , n ,
g a a a
Active , n
a
(n /N ) % (n /N ) % (n /N ) %
a tot a tot a tot
Explanation of symbols:
n represents the number of subjects associated with the form for that type of information.
(n/N ) % represents the percentage of subjects associated with the form of that type of information with
tot
respect to the total number of subjects enrolled in the study.
a
“Enrolled” or N represents the total number of subjects enrolled in the investigation.
tot
b
“Available for analysis” or n represents the total number of subjects for whom data is available at the
aa
form.
c
“Discontinued” or n represents the total number of subjects that have discontinued treatment prior to the
d
form for any reason (e.g. death or device replacement). This category doesn’t include subjects that are lost to
follow-up.
d
“Missing at final scheduled visit but seen later” or n represents the total number of subjects that were
sl
seen outside the time window associated with the form.
e
“Not seen but accounted for” or n represents the total number of subjects that were missing at the
ns
scheduled visit but were accounted for by being contacted (e.g. by phone).
f
“Lost to follow-up” or n represents the total number of subjects that have missed the form and there is no
lf
information available about them.
g
“Active” or n represents the total number of subjects that have not reached the time associated with the
a
form. The investigation at the form is considered completed when the number of active subjects is zero.
The following equation is used to determine the percent accountability, % N , for the investigation.
account
n
aa
% N =
account
Nn−−n
tot d a
where n , N , n and n are as defined in Table A.1.
aa tot d a
6 © ISO 2006 – All rights reserved
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ISO 11979-7:2006(E)
Depending upon the clinical investigation, the total number of subjects is not necessarily the total number of
eyes. For the purposes of this guidance, it is assumed that treatment is unilateral and that the total number of
subjects is equivalent to the total number of eyes.
To minimize the uncertainty in the data, the lost-to-follow-up subjects in the three-year investigation should be
less than 30 % and the lost-to-follow-up in one-year investigation should be less than 10 %.
A.8 Clinical case report forms
The next pages provide examples of the following case report forms:
a) pre-operative/operative case report form — posterior chamber lenses (Table A.2);
b) post-operative case report form — posterior chamber lenses (Table A.3);
c) pre-operative/operative case report form — anterior chamber lenses (Table A.4);
d) post-operative case report form — anterior chamber lenses (Table A.5);
e) adverse event case report form (Table A.6).
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ISO 11979-7:2006(E)
Table A.2 — Pre-operative/ operative case report form for posterior chamber lens clinical investigation
Investigator name: _________________________________________ Clinical trial number: _ _ _ _
Patient number: _ _ _ _ Patient initials: ______ Sex: Male: † Race: Caucasian †
Female: † Black †
Asian †
Date of birth: Other †
YY MM DD
Mixed †
Pre-operative report _ _ _ _ _ _ Irrigating solution used yes no
YY MM DD
† †
Operative eye right † left † If yes, specify ______________________
Operative eye Fellow eye Periocular medication yes (specify, if appropriate) no
Best corrected visual acuity _____ _____ Anaesthetic † ______________________ †
or check one: Antibiotic † ______________________ †
Finger count † † Corticosteroid † ______________________ †
Hand movement † † Other (specify) † ______________________ †
Light perception † † Incision
No light perception † †
Size ____________ mm
IOP (applanation): Op. eye: ___ mmHg Fellow eye: ___ mmHg
Type (e.g., corneal, limbal, scleral tunnel) ______________
Corneal status (check yes or no for each) yes no
Normal † † Type of lens extraction (check one)
Guttata † †
Other pathology (specify) _______________ † † Phacoemulsification †
Cataract Other (specify) __________________________ †
Etiology (check one) senile † Type of capsulotomy (check one)
other (specify)___________ † CCCR (continuous curvilinear capsulorhexis) †
Pathology (check yes or no for each) yes no not assessable Other (specify) __________________________ †
Pseudoexfoliation † †
Glaucoma † † Position of the loops (check one) in the bag †
Previous glaucoma filtering surgery † † partly in the bag †
Poor pupil dilation † † in the sulcus †
Previous uveitis † † uncertain †
Previous retinal detachment † † yes no
Diabetic retinopathy † † † Other surgical procedures (check yes or no) † †
Macular degeneration † † † If yes, specify: _____________________
Amblyopia † †
Other (specify) _____________ † † Problems during surgery (check yes or no for each) yes no
Anterior segment bleeding † †
Biometry K1________D Axial length_____mm
K2________D
Iris damage † †
Target postoperative refraction _______________________ Posterior capsular opacity remaining † †
Posterior capsular rupture † †
Signed informed yes † _ _ _ _ _ _
consent obtained:
DD MM YY
Anterior vitrectomy † †
Other(specify) ________________ † †
Operative report Date of surgery _ _ _ _ _ _ If investigation lens not implanted indicate reason:
DD MM YY
__________________________________________________
Ophthalmic viscosurgical device used yes † no †
If yes, specify ____________ Lens implanted. Place label here:
Intraocular medication (check yes or no for yes no
each)
† †
Time incision to closure ____________ min.
Adrenalin
Acetylcholine † † Signature of investigator
Carbachol † †
Other (specify) ___________________ † † _ _ _ _ _ _
YY MM DD
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ISO 11979-7:2006(E)
Table A.3 — Post-operative case report form for posterior chamber lens clinical investigation
Investigator name: _________________________________________ Clinical trial number: _ _ _ _
Patient number: _ _ _ _ Patient initials: ______ Date of birth: _ _ _ _ _ _
YY MM DD
_ _ _ _ _ _ Other pathology and complications (Continued)
Post-operative report
YY MM DD
present absent
Eye right † left † Fibrin in pupil † †
Check if the patient is unavailable for this scheduled examination † Cortical remnants † †
but continuing in the clinical investigation (sign form with all
Nuclear remnants † †
evaluation in form left blank)
IOL optic decentration † †
If the patient is discontinued from the investigation, indicate
if present: ____ mm
primary reason:
IOL optic tilt † †
_______________________________________________
if present: _____degrees
Refraction Sphere _____________ IOL dislocation out of the posterior chamber † †
Cylinder _____________ IOL optic discoloration † †
Axis _____________ IOL optic opacities † †
Keratometry K1________D Retinal detachment † †
K2________D
Diabetic retinopathy † †
Op. eye Fellow Cystoid macular oedema † †
Best corrected visual acuity eye
if present diagnosed:
______ ______
clinically †
by fluorescein angiography †
or check one Finger count † † Macular degeneration † †
Hand movement † † Optic atrophy † †
Light perception † † yes no
No light perception † † Anterior capsular opacification present? † †
IOP (application) _______________ mm Hg Is the posterior capsule intact? † †
Medications used up to this visit topical systemic if intact:
(check yes or no for each) yes no yes no posterior capsule fibrosis † †
Corticosteroids † † † † Elschnig’s pearls † †
Antibiotics † † † † if not intact:
NSAIDs † † † † has the capsule been opened since
Glaucoma medication † † † † the last reported visit? † †
Other (specify) ____________________________________________ Other pathology? † †
Corneal stromal oedema wound central specify:___________________________________________
none † †
mild/moderate † † If visual acuity less than 0,5 (20/40, 6/12) indicate main
severe † † reason:
_________________________________________________
Iritis (check one) none †
mild †
_________________________________________________
moderate † Has the operated eye undergone any surgical yes no
severe † reintervention since last reported visit? †
†
Other pathology and complications present absent If yes, specify:
(check present or absent for each)
_________________________________________________
Wound leak
†
†
Has the patient experienced any adverse yes no
Flat anterior chamber
†
event or ophthalmic adverse device effect?
†
† †
Hyphema
†
†
Endophthalmitis
†
†
if present
infectious † If yes, fill in the adverse event/ adverse device effect report
form.
sterile †
V
...
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